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14 http://www.mepa.org.mt/file.aspx?f=6847; Directive 2002/49/EC of the European Parliament http://bib.irb.hr/datoteka/202624.718-0.pdf; and of the Council of 25 June 2002 relating to the Legally EU Regional http://www.epa.ie/downloads/advice/Noisema assessment and management of environmental binding pping/EPA%20Guidance%20Note%20for%20No noise ise%20Action%20Planning.pdf Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing Legally http://ec.europa.eu/environment/pubs/pdf/fac EU Regional a framework for Community action in the field of binding tsheets/water-framework-directive.pdf

water policy Directive 2006/118/EC of the European Parliament http://circa.europa.eu/Public/irc/env/wfd/libra of the Council of 12 December 2006 on the Legally EU Regional ry?l=/framework_directive/guidance_documen protection of groundwater against pollution and binding

ts/guidance_n18pdf/_EN_1.0_&a=d deterioration Commission Directive 2009/90/EC of 31 July 2009 laying down, pursuant to Directive 2000/60/EC of Legally http://ec.europa.eu/environment/water/water the European Parliament and of the Council, EU Regional

binding -dangersub/index.htm#technical technical specifications for chemical analysis and monitoring of water status Directive 2006/7/EC or the European Parliament and of the Council of 15 February 2006 concerning Legally http://ec.europa.eu/environment/water/water EU Regional the management of bathing water quality and binding -bathing/report_2012.html repealing Directive 76/160/EEC http://eur- Directive 2008/1/EC of the European Parliament Legally lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ and of the Council of 15 January 2008 concerning EU Regional binding :L:2008:024:0008:0029:en:PDF integrated pollution prevention and control

Council Directive 91/676/EEC of 12 December 1991 http://eur- concerning the protection of water against Legally EU Regional lex.europa.eu/LexUriServ/LexUriServ.do?uri=CE pollution caused by nitrates from agricultural binding

LEX:52002DC0407:EN:NoT sources Legally http://ec.europa.eu/clima/policies/lowcarbon/

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binding ccs/implementation/index_en.htm Kiev Protocol on Pollutant Release and Transfer Legally http://www.unece.org/fileadmin/DAM/env/pp UNECE Regional

Registers binding /prtr/guidance/PRTR_May_2008_for_CD.pdf http://www.unece.org/env/pp/related.html; http://www.unece.org/fileadmin/DAM/env/pp Convention on access to information, public Legally /Implementation%20reports%202008/Estonia_ participation and access to justice in UNECE Regional binding as_submitted_2007_12_3.pdf; environmental matters (Aahrus Convention) http://www.unece.org/fileadmin/DAM/env/pp /acig.pdf

15 Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of Legally http://gmo- EU Regional genetically modified organisms and repealing binding crl.jrc.ec.europa.eu/statusofdoss.htm Council Directive 90/220/EEC – Commission

Declaration The Vienna Convention for the Protection of the United Legally

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binding ercury/pdf/extended_impact_assessment.pdf certain mercury compounds and mixtures and the

safe storage of metallic mercury Non- Exposure to mercury: a major public health WHO Global legally n/a concern binding http://www.euro.who.int/en/what-we- Non- Rio+20 United Nations Conference on Sustainable United do/health-topics/environment-and- Global legally

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Bahia Declaration on Chemical Safety WHO Global

legally _5/inf5-8/inf8.pdf

16 binding

http://library.certh.gr/libfiles/PDF/SPIN-321- EU-ASSESSMNT-TOOLS-NEW-EU-CHEMICALS- POLICY-REACH040122-PP15-Y-2003.pdf; http://ec.europa.eu/enterprise/sectors/chemic als/documents/reach/review2012/baseline_en. Legally htm; Environment: Chemicals EU Regional binding http://ec.europa.eu/enterprise/sectors/chemic als/documents/reach/review2012/restrictions_ en.htm; http://ec.europa.eu/enterprise/sectors/chemic als/documents/reach/review2012/health_env_ benefits_en.htm Directive 2004/35/CE of the European Parliament and of the Council of 21 April 2004 on http://europa.eu/legislation_summaries/enter Legally environmental liability with regard to the EU Regional prise/interaction_with_other_policies/l28120_ binding prevention and remedying of environmental en.htm

damage Directive 2008/99/EC of the European Parliament http://europa.eu/legislation_summaries/justice and of the Council of 19 November 2008 on the Legally EU Regional _freedom_security/fight_against_organized_cri protection of the environment through criminal binding

me/ev0012_en.htm law Council Directive 91/271/EEC of 21 May 1991 Legally http://ec.europa.eu/environment/legal/imple EU Regional concerning urban waste water treatment binding mentation_en.htm Commission Directive 98/15/EC of 27 February http://eur- 1998 amending Council Directive 91/271/EEC with Legally lex.europa.eu/Result.do?direct=yes&lang=en& EU Regional respect to certain requirements established in binding where=LB%3A31991L0271&whereihm=Base+ju

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17 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of Legally http://echa.europa.eu/web/guest/regulations/ EU Regional substances and mixtures amending and repealing binding clp/legislation Directives 67/548/EEC and 1999/45/EC, and

amending Regulation (EC) No 1907/2006 Communication COM(2005) 446 final from the Legally Commission to the Council and the European EU Regional binding http://ec.europa.eu/environment/air/review_a

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binding egislation/index.htm management Council Directive 1999/30/EC of 22 April 1999 relating to limit values for sulphur dioxide, nitrogen Legally http://ec.europa.eu/environment/air/pdf/1999 EU Regional dioxide and oxides of nitrogen, particulate matter binding _30_ec_review_report.pdf

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18 Commission Decision 2004/461/EC of 29 April 2004 laying down a questionnaire for annual reporting on ambient air quality assessment under Council Legally http://ec.europa.eu/environment/air/quality/l EU Regional

Directives 96/62/EC and 1999/30/EC and under binding egislation/reporting.htm Directives 2000/69/EC and 2002/3/EC of the

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Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 Legally http://ec.europa.eu/environment/biocides/imp EU Regional concerning the making available on the market and binding lementation.htm

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21 Directive 2007/30/EC of the European Parliament and the Council of 20 June 2007 amending Council Directive 89/391/EEC, its individual Directives and http://eur- Legally Council Directives 83/477/EEC, 91/383/EEC, EU Regional lex.europa.eu/LexUriServ/LexUriServ.do?uri=CE binding

92/29/EEC and 94/33/EC with a view to simplifying LEX:52004DC0062:EN:NoT and rationalising the reports on practical

implementation Directive 2009/104/EC – use of work equipment concerning the minimum safety and health http://eur- requirements for the use of work equipment by Legally EU Regional lex.europa.eu/LexUriServ/LexUriServ.do?uri=CE workers at work (second individual Directive within binding

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89/391/EEC) Directive 1999/92/EC of 16 December 1999 on minimum requirements for improving the safety Legally http://www.ohsa.org.mt/showpage.asp?pageid EU Regional and health protection of workers potentially at risk binding =202

from explosive atmospheres Directive 92/58/EEC of 24 June 1992 on the http://eur- Legally minimum requirements for the provision of safety EU Regional lex.europa.eu/LexUriServ/LexUriServ.do?uri=CE binding and/or health signs at work LEX:71992L0058:EN:NoT http://eur- Directive 89/656/EEC of 30 November 1989 on the lex.europa.eu/LexUriServ/LexUriServ.do?uri=CE minimum health and safety requirements for the Legally LEX:71989L0656:EN:NoT; EU Regional use by workers of personal protective equipment binding http://europa.eu/legislation_summaries/emplo

at the workplace yment_and_social_policy/health_hygiene_safe ty_at_work/c11149_en.htm http://europa.eu/legislation_summaries/emplo Directive 89/654/EEC of 30 November 1989 yment_and_social_policy/health_hygiene_safe Legally concerning the minimum safety and health EU Regional ty_at_work/c11149_en.htm; http://eur- binding requirements for the workplace lex.europa.eu/LexUriServ/LexUriServ.do?uri=CE LEX:71989L0654:EN:NoT Directive 2009/161/EU of 17 December 2009 establishing a third list of indicative occupational http://eur- Legally exposure limit values in implementation of Council EU Regional lex.europa.eu/LexUriServ/LexUriServ.do?uri=CE binding

Directive 98/24/EC and amending Commission LEX:72009L0161:EN:NoT

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22 LEX:72009L0148:EN:NoT

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Directive 2000/39/EC of 8 June 2000 establishing a first list of indicative occupational exposure limit http://eur- values in implementation of Council Directive Legally EU Regional lex.europa.eu/LexUriServ/LexUriServ.do?uri=CE 98/24/EC on the protection of the health and binding

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agents at work Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of Legally EU Regional n/a substances and mixtures, amending and repealing binding Directives 67/548/EEC and 1999/45/EC, and

amending Regulation (EC) No 1907/2006 Directive 2008/68/EC of the European Parliament http://eur- Legally and of the Council of 24 September 2008 on the EU Regional lex.europa.eu/LexUriServ/LexUriServ.do?uri=CE binding inland transport of dangerous goods LEX:72008L0068:EN:NoT

23 Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the http://eur- approximation of the laws, regulations and Legally EU Regional lex.europa.eu/LexUriServ/LexUriServ.do?uri=CE administrative provisions of the Member States binding

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LEX:72004L0040:EN:NoT Art. 16(1) of Directive 89/391/EEC) as amended by Directive 2012/11/EU of 19 April 2012 extending

the deadline for transposition to 31 October 2013 Directive 2003/10/EC of 6 February 2003 on the http://eur- minimum health and safety requirements Legally EU Regional lex.europa.eu/LexUriServ/LexUriServ.do?uri=CE regarding the exposure of workers to the risks binding

LEX:72003L0010:EN:NoT arising from physical agents (noise) Directive 2002/44/EC of the of 25 June 2002 on the http://eur- minimum health and safety requirements Legally EU Regional lex.europa.eu/LexUriServ/LexUriServ.do?uri=CE regarding the exposure of workers to the risks binding

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24 http://eur- Directive 96/29/Euratom of 13 May 1996 laying lex.europa.eu/LexUriServ/LexUriServ.do?uri=CE down basic safety standards for the protection of Legally LEX:71996L0029:EN:NoT; EU Regional the health of workers and the general public binding http://www.ncbi.nlm.nih.gov/sites/entrez?Db=

against the dangers arising from ionizing radiation pubmed&Cmd=Retrieve&list_uids=16832973& dopt=abstractplus http://eur- Directive 2009/71/Euratom of 25 June 2009 lex.europa.eu/LexUriServ/LexUriServ.do?uri=CE Legally establishing a Community framework for the EU Regional LEX:72009L0071:EN:NoT; binding nuclear safety of nuclear installations http://ec.europa.eu/energy/nuclear/safety/saf ety_en.htm http://eur- lex.europa.eu/LexUriServ/LexUriServ.do?uri=CE Directive 2004/108/EC of the European Parliament LEX:72004L0108:EN:NoT; and of the Council of 15 December 2004 on the Legally http://ec.europa.eu/enterprise/policies/single- approximation of the laws of the Member States EU Regional binding market-goods/regulatory-policies-common- relating to electromagnetic compatibility and rules-for-products/new-legislative-framework/; repealing Directive 89/336/EEC http://ec.europa.eu/enterprise/sectors/electric al/files/emcguide_may2007_en.pdf Directive 2003/122/Euratom of 22 December 2003 http://eur- Legally on the control of high-activity sealed radioactive EU Regional lex.europa.eu/LexUriServ/LexUriServ.do?uri=CE binding sources and orphan sources LEX:72003L0122:EN:NoT http://eur- Directive 2000/14/EC of the European Parliament lex.europa.eu/LexUriServ/LexUriServ.do?uri=CE and of the Council of 8 May 2000 on the LEX:72000L0014:EN:NoT; Legally approximation of the laws of the Member States EU Regional http://ec.europa.eu/enterprise/sectors/mecha binding relating to the Noise emission in the environment nical/documents/guidance/noise-

by equipment for use outdoors emissions/index_en.htm; http://www.bis.gov.uk/files/file11981.pdf Directive 2000/54/EC of the European Parliament http://eur- and of the Council of 18 September 2000 on the Legally EU Regional lex.europa.eu/LexUriServ/LexUriServ.do?uri=CE protection of workers from risks related to binding

LEX:72000L0054:EN:NoT exposure to biological agents at work http://eur- lex.europa.eu/LexUriServ/LexUriServ.do?uri=CE LEX:71990L0270:EN:NoT; Directive 90/270/EEC of 29 May 1990 on the Legally http://www.szu.cz/uploads/documents/cpl/Ver minimum safety and health requirements for work EU Regional binding ze_AJ/VDU_CZ_National_Report.pdf; with display screen equipment http://europa.eu/legislation_summaries/emplo yment_and_social_policy/health_hygiene_safe ty_at_work/c11149_en.htm

25 http://europa.eu/legislation_summaries/emplo Directive 90/269/EEC of 29 May 1990 on the yment_and_social_policy/health_hygiene_safe minimum health and safety requirements for the Legally EU Regional ty_at_work/c11149_en.htm; http://eur- manual handling of loads where there is a risk binding lex.europa.eu/LexUriServ/LexUriServ.do?uri=CE particularly of back injury to workers LEX:71989L0654:EN:NoT; http://eur- Directive 2003/88/EC of 4 November 2003 lex.europa.eu/LexUriServ/LexUriServ.do?uri=CE Legally concerning certain aspects of the organization of EU Regional LEX:72003L0088:EN:NoT; http://eur- binding working time lex.europa.eu/LexUriServ/LexUriServ.do?uri=C OM:2010:0802:FIN:EN:PDF http://eur- Directive 2002/15/EC of 11 March 2002 on the lex.europa.eu/LexUriServ/LexUriServ.do?uri=CE Legally organization of the working time of persons EU Regional LEX:72002L0015:EN:NoT; http://www.europa- binding performing mobile road transport activities nu.nl/id/vi7eat2sjuzs/commission_staff_workin g_document Directive 2000/79/EC of 27 November 2000 concerning the European Agreement on the Organization of Working Time of Mobile Workers in Civil Aviation. Concluded by the Association of http://eur- Legally European Airlines (AEA), the European Transport EU Regional lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ binding

Workers’ Federation (ETF), the European Cockpit :L:2000:302:0057:0060:EN:PDF Association (ECA), the European Regions Airline Association (ERA) and the International Air Carrier Association (IACA) Directive 2010/32/EU of 10 May 2010 http://eur- implementing the Framework Agreement on lex.europa.eu/LexUriServ/LexUriServ.do?uri=CE Legally prevention from sharp injuries in the hospital and EU Regional LEX:72010L0032:EN:NoT; binding health care sector concluded by HOSPEEM and http://www.europeanbiosafetynetwork.eu/res

EPSU ources http://eur- lex.europa.eu/LexUriServ/LexUriServ.do?uri=CE Directive 94/33/EC of 22 June 1994 on the Legally EU Regional LEX:71994L0033:EN:NoT; protection of young people at work binding http://ec.europa.eu/social/main.jsp?catId=706 &langId=en&intPageId=209 http://eur- lex.europa.eu/LexUriServ/LexUriServ.do?uri=CE Directive 93/103/EC of 23 November 1993 Legally LEX:71993L0103:EN:NoT; concerning the minimum safety and health EU Regional binding https://osha.europa.eu/en/legislation/directive requirements for work on board fishing vessels s/sector-specific-and-worker-related- provisions/osh-directives/17

26 http://eur- Directive 92/104/EEC of 3 December 1992 on the lex.europa.eu/LexUriServ/LexUriServ.do?uri=CE minimum requirements for improving the safety Legally EU Regional LEX:71992L0104:EN:NoT; http://eur- and health protection of workers in surface and binding lex.europa.eu/LexUriServ/LexUriServ.do?uri=CE underground mineral-extracting industries LEX:52009DC0449:EN:NoT Directive 92/91/EEC of 3 November 1992 http://eur- concerning the minimum requirements for lex.europa.eu/LexUriServ/LexUriServ.do?uri=CE Legally improving the safety and health protection of EU Regional LEX:71992L0091:EN:NoT; http://eur- binding workers in the mineral-extracting industries lex.europa.eu/LexUriServ/LexUriServ.do?uri=CE

through drilling LEX:52009DC0449:EN:NoT http://eur- Directive 92/85/EEC of 19 October 1992 on the lex.europa.eu/LexUriServ/LexUriServ.do?uri=CE introduction of measures to encourage Legally LEX:71992L0085:EN:NoT; improvements in the safety and health at work of EU Regional binding https://osha.europa.eu/en/legislation/directive pregnant workers and workers who have recently s/sector-specific-and-worker-related- given birth or are breastfeeding provisions/osh-directives/10 Directive 92/57/EEC –of 24 June 1992 on the http://eur- implementation of minimum safety and health Legally EU Regional lex.europa.eu/LexUriServ/LexUriServ.do?uri=CE requirements at temporary or mobile construction binding

LEX:71992L0057:EN:NoT sites http://eur- lex.europa.eu/LexUriServ/LexUriServ.do?uri=CE Directive 92/29/EEC of 31 March 1992 on the Legally LEX:71992L0029:EN:NoT; minimum safety and health requirements for EU Regional binding https://osha.europa.eu/en/legislation/directive improved medical treatment on board vessels s/sector-specific-and-worker-related- provisions/osh-directives/17 Directive 91/383/EEC of 25 June 1991 http://eur- supplementing the measures to encourage lex.europa.eu/LexUriServ/LexUriServ.do?uri=CE improvements in the safety and health at work of Legally EU Regional LEX:71991L0383:EN:NoT; workers with a fixed-duration employment binding http://ec.europa.eu/social/main.jsp?catId=706 relationship or a temporary employment &langId=en&intPageId=200 relationship http://eur- Directive 2008/104/EC of 19 November 2008 on Legally EU Regional lex.europa.eu/LexUriServ/LexUriServ.do?uri=CE temporary agency work binding LEX:72008L0104:EN:NoT;

27 Directive 2002/73/EC of 23 September 2002 amending Council Directive 76/207/EEC on the http://eur- implementation of the principle of equal treatment Legally EU Regional lex.europa.eu/LexUriServ/LexUriServ.do?uri=CE for men and women as regards access to binding

LEX:72002L0073:EN:NoT employment, vocational training and promotion,

and working conditions

Directive 2000/78/EC of 27 November 2000, http://eur- Legally establishing a general framework for equal EU Regional lex.europa.eu/LexUriServ/LexUriServ.do?uri=CE binding treatment in employment and occupation LEX:72000L0078:EN:NoT

Legally http://europa.eu/legislation_summaries/transp

Directives and regulations – road traffic EU Regional binding ort/road_transport/index_en.htm

http://eur- Directive 2009/38/EC of 6 May 2009, on the lex.europa.eu/LexUriServ/LexUriServ.do?uri=CE establishment of a European Works Council or a Legally EU Regional LEX:72009L0038:EN:NoT; procedure in undertakings for the purposes of binding http://ec.europa.eu/social/main.jsp?catId=707 informing and consulting employees &langId=en&intPageId=211 Non- http://eur- European Community Strategy for Health and EU Regional legally lex.europa.eu/LexUriServ/LexUriServ.do?uri=C

Safety at Work (2007–2012)

binding OM:2007:0062:FIN:en:PDF Council Resolution of 25 June 2007 on a new Non- http://eur- Community strategy on health and safety at work EU Regional legally lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ

(2007–2012) binding :C:2007:145:0001:0004:EN:PDF Council Directive 89/391 of 12 June 1989 on the https://osha.europa.eu/data/links/guidance- introduction of measures to encourage Legally on-risk-assessment-at- EU Regional improvements in the safety and health of workers binding work?utm_source=oshmail&utm_medium=em

at work – "Framework Directive" ail&utm_campaign=index_html http://eur- Improving quality and productivity at work – Non- lex.europa.eu/LexUriServ/LexUriServ.do?uri=C Community strategy 2007–2012 on health and EU Regional legally OM:2007:0062:FIN:en:PDF safety at work binding

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health of EU workers binding Non-binding guide to good practice for Non- implementing Directive 2001/45/EC (Work at a EU Regional legally n/a

height) binding

28 Non-binding guide to good practice for Non- implementing Directive 1999/92/EC “ATEX” EU Regional legally n/a

(explosive atmospheres) binding http://eur- Non- lex.europa.eu/LexUriServ/LexUriServ.do?uri=SE

Framework agreement on telework EU Regional legally C:2008:2178:FIN:EN:PDF&utm_source=oshmail binding &utm_medium=e-

mail&utm_campaign=index_html Non- A practical guide on best practice to prevent or EU Regional legally n/a minimise asbestos risks binding Practical guidelines of a non-binding nature on the Non- protection of the health and safety of workers EU Regional legally n/a

from the risks related to chemical agents at work binding Agreement on Workers Health Protection through Non- the Good Handling and Use of Crystalline Silica and EU Regional legally n/a

Products containing it binding Communication COM/2008/0366 final from the Commission to the European Parliament, the Non- Council and the European Economic and Social EU Regional legally n/a Committee – Regulatory aspects of nanomaterials binding

[SEC(2008) 2036] Communication COM/2005/0243 final from the Commission to the Council, the European Non- Parliament and the Economic and Social EU Regional legally Committee - Nanosciences and nanotechnologies: binding http://www.framingnano.eu/index.php?option

an action plan for Europe 2005–2009 =com_content&task=view&id=152&Itemid=40 Communication COM/2004/0338 final from the Non- Commission – Towards a European Strategy for EU Regional legally

Nanotechnology binding Non- http://echa.europa.eu/web/guest/guidance-

ECHA Guidance EU Regional legally documents/guidance-on-information-

binding requirements-and-chemical-safety-assessment Non-

Labelling and Safety Data Sheets (CLP) EU Regional legally n/a binding Non- Evaluation of the implementation of radiation EU Regional legally n/a protection measures for aircrew binding Non-binding guide to good practice for Non- EU Regional n/a implementing Directive 2006/25/EC ‘artificial legally

29 optical radiation’ binding

Technical recommendations for monitoring Non- individuals occupationally exposed to external EU Regional legally n/a

radiation binding Council Directive 96/29/Euratom of 13 May 1996 http://eur- laying down basic safety standards for the lex.europa.eu/LexUriServ/LexUriServ.do?uri=CE Legally protection of the health of workers and the EU Regional LEX:71996L0029:EN:NoT; binding general public against the dangers arising from http://ec.europa.eu/governance/impact/ia_car

ionizing radiation ried_out/docs/ia_2011/sec_2011_1097_en.pdf Non-binding guide to good practice for the application of Directive 2003/10/EC of the Non- European Parliament and of the Council on the EU Regional legally n/a minimum safety and health requirements binding regarding the exposure of workers to the risks

arising from physical agents (Noise) Non-binding guide to good practice with a view to implementation of Directive 2002/44/EC on the Non- minimum health and safety requirements EU Regional legally n/a regarding the exposure of workers to the risks binding

arising from physical agents (vibrations) http://ec.europa.eu/health/ph_determinants/e Council Recommendation 1999/519/EC on the Non- nvironment/EMF/implement_rep_en.pdf?utm_ limitation of exposure of the general public to EU Regional legally source=oshmail&utm_medium=email&utm_ca electromagnetic fields (0 Hz to 300 GHz) binding

mpaign=index_html European agreement on the reduction of workers’ Non- exposure to the risk of work-related musculo- EU Regional legally n/a

skeletal disorders in agriculture binding Non- Framework agreement on harassment and http://www.etuc.org/IMG/pdf/BROCHURE_har EU Regional legally violence at work assment7_2_.pdf binding Non- Report on the implementation of the European

Framework agreement on work-related stress EU Regional legally social partners’ Framework Agreement on

binding Work-related Stress Non- Guidance on work-related stress: Spice of life or EU Regional legally n/a kiss of death binding Occupational health and safety risks in the Non- healthcare sector – Guide to prevention and good EU Regional legally n/a

practice binding

30 Non-binding guide to good practice for understanding and implementing Directive Non- 92/57/EEC on the implementation of minimum EU Regional legally n/a safety and health requirements at temporary or binding

mobile construction sites Non- Framework agreement on prevention from sharp EU Regional legally n/a injuries in the hospital and healthcare binding Council recommendation of 18 February 2003 concerning the improvement of the protection of Legally EU Regional n/a the health and safety at work of self-employed binding

workers Guidelines on the assessment of the chemical, physical and biological agents and industrial Non- processes considered hazardous for the safety or EU Regional legally n/a health of pregnant workers and workers who have binding recently given birth or are breastfeeding

(92/85/EEC) Commission Recommendation of 19 September Non- 2003 concerning the European schedule of EU Regional legally n/a

occupational diseases binding Non-

European Schedule of Occupational Diseases EU Regional legally n/a binding Practical guidelines of a non-binding nature on the Non- protection of the health and safety of workers EU Regional legally n/a

from the risks related to chemical agents at work binding Non-

Declaration on occupational health for all WHO Global legally n/a binding http://www.euro.who.int/en/what-we- Non- do/health-topics/environment-and-

Workers’ Health: global plan of action WHO Global legally health/occupational- binding health/publications/2010/global-plan-of-

action-of-workers-health Non- GOHNET (Global Occupational Health Network) WHO Global legally n/a newsletter binding

31 United Nations/ Convention concerning Occupational Safety and International Legally Global n/a

Health and the Working Environment Labour binding Organization (ILO) Convention concerning the promotional Legally ILO Global n/a

framework for occupational safety and health binding Non- The Seoul Declaration on Safety and Health at

ILO Global legally http://www.seouldeclaration.org/en/Resources

Work binding European programme for action to tackle the Non- http://ec.europa.eu/development/icenter/repo critical shortage of health workers in developing EU Regional legally sitory/health_progress_report_implementation

countries (2007–2013) binding _2008_en.pdf Non- WHO global strategy for food safety: safer food for http://www.who.int/foodsafety/capacity/links/ WHO Global legally

better health en/index.html binding Non- WHO/United http://www.codexalimentarius.org/meetings-

Codex Alimentarius Global legally

Nations reports/en/ binding Non- WHO/United

Codex Alimentarius Standards Global legally n/a Nations binding Non- http://ec.europa.eu/dgs/health_consumer/libr

White Paper on Food Safety EU Regional legally

ary/pub/pub06_en.pdf binding Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and Legally http://europa.eu/legislation_summaries/consu C. Food safety Food C. EU Regional

requirements of food law, establishing the binding mers/consumer_information/f80501_en.htm European Food Safety Authority and laying down

procedures in matters of food safety Commission Regulation (EC) No 2230/2004 of 23 December 2004 laying down detailed rules for the implementation of European Parliament and Legally Council Regulation (EC) No 178/2002 with regard EU Regional n/a binding to the network of organizations operating in the fields within the European Food Safety Authority’s

mission

32 Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and Legally http://ec.europa.eu/food/food/chemicalsafety EU Regional requirements of food law, establishing the binding /residues/residues_paper_2003_en.pdf European Food Safety Authority and laying down procedures in matters of food safety Legally http://ec.europa.eu/food/food/rapidalert/rasff

Rapid Alert System for Food and Feed EU Regional

binding _portal_database_en.htm Modus Operandi for the management of new food Non- safety incidents with a potential for extension EU Regional legally n/a

involving a chemical substance binding Regulation (EC) No 767/2009 of the European Parliament and of the Council of 13 July 2009 on the placing on the market and use of feed, amending European Parliament and Council Regulation (EC) No 1831/2003 and repealing Legally http://ec.europa.eu/food/fvo/act_getPDF.cfm? EU Regional

Council Directive 79/373/EEC, Commission binding PDF_ID=9001 Directive 80/511/EEC, Council Directives 82/471/EEC, 83/228/EEC, 93/74/EEC, 93/113/EC and 96/25/EC and Commission Decision

2004/217/EC Commission Regulation (EU) No 575/2011 of 16 Legally EU Regional n/a

June 2011 on the Catalogue of feed materials binding Commission Regulation (EU) No 454/2010 of 26 May 2010 on on transitional measures under Legally http://ec.europa.eu/food/fvo/act_getPDF.cfm? Regulation (EC) No 767/2009 of the European EU Regional

binding PDF_ID=9001 Parliament and of the Council as regards the

labelling provisions for feed Commission Regulation (EU) No 939/2010 of 20 October 2010 amending Annex IV to Regulation Legally (EC) No 767/2009 on permitted tolerances for the EU Regional n/a binding compositional labelling of feed materials or

compound feed as referred to in Article 11(5)

33 Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) http://ec.europa.eu/food/food/labellingnutriti No 1925/2006 of the European Parliament and of on/foodlabelling/publications/ia_general_food the Council, and repealing Commission Directive Legally _labelling.pdf; EU Regional 87/250/EEC, Council Directive 90/496/EEC, binding http://ec.europa.eu/food/food/labellingnutriti Commission Directive 1999/10/EC, Directive on/foodlabelling/publications/ia_nutrition_lab

2000/13/EC of the European Parliament and of the elling.pdf Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No

608/2004 Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the Legally http://www.rand.org/pubs/technical_reports/2 approximation of the laws of the Member States EU Regional

binding 008/RAND_TR532.pdf relating to the labelling, presentation and

advertising of foodstuffs http://ec.europa.eu/food/food/labellingnutriti Council Directive 90/496/EEC of 24 September Legally EU Regional on/foodlabelling/publications/ia_nutrition_lab

1990 on nutrition labelling for foodstuffs binding

elling.pdf Commission Directive 2008/100/EC of 28 October 2008 amending Council Directive 90/496/EEC on Legally http://ec.europa.eu/food/food/labellingnutriti nutrition labelling for foodstuffs as regards EU Regional

binding on/nutritionlabel/impact_assessment.pdf recommended daily allowances, energy conversion

factors and definitions Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive Legally EU Regional n/a 87/250/EEC, Council Directive 90/496/EEC, binding Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No

608/2004 Regulation (EC) No 1760/2000 of the European Parliament and of the Council of 17 July 2000 Legally http://ec.europa.eu/agriculture/publi/reports/ EU Regional establishing a system for the identification and binding beeflabel/fullrep_en.pdf registration of bovine animals and regarding the

34 labelling of beef and beef products and repealing Council Regulation (EC) No 820/97

Commission Directive 2001/101/EC of 26 November 2001 amending Directive 2000/13/EC of the European Parliament and of the Council on the Legally http://ec.europa.eu/food/food/labellingnutriti EU Regional approximation of the laws of the Member States binding on/foodlabelling/comm_legisl_en.htm relating to the labelling, presentation and

advertising of foodstuffs Directive 2003/89/EC of the European Parliament and of the Council amending Directive 2000/13/EC Legally http://ec.europa.eu/food/food/labellingnutriti EU Regional as regards indication of the ingredients present in binding on/foodlabelling/comm_legisl_en.htm

foodstuffs Guidelines relating to article 6 paragraph 10 of Legally Directive 2000/13/EC as amended by Directive EU Regional n/a binding

2003/89/EC Guidelines from the Commission services for the Non- contents of the notifications requested by new EU Regional legally n/a paragraph 11 of Directive 2000/13/EC, as amended binding by Directive 2003/89/EC Commission Directive 2005/26/EC of 21 March 2005 establishing a list of food ingredients or Legally Evaluation of the food labelling legislation substances provisionally excluded from Annex IIIa EU Regional

binding FINAL REPORT Main Text of Directive 2000/13/EC of the European

Parliament and of the Council Second administrative guidance from the Non- http://ec.europa.eu/food/food/labellingnutriti Commission services for the application of article 6 EU Regional legally on/foodlabelling/publications/ia_general_food

paragraph 11 of Directive 2000/13/EC binding _labelling.pdf Directive 98/6/EC of the European Parliament and of the Council of 16 February 1998 on on consumer Legally http://ec.europa.eu/consumers/cons_int/safe_ EU Regional protection in the indication of the prices of binding shop/price_ind/disclaimer_en.pdf

products offered to consumers Commission Directive No 2002/67/EC of 18 July Legally 2002 on the labelling of foodstuffs containing EU Regional n/a binding quinine, and of foodstuffs containing caffeine

35 http://ec.europa.eu/food/food/biotechnology/ evaluation/evaluation_documents_en.htm; Regulation (EC) No 1829/2003 of the European Legally http://ec.europa.eu/food/food/biotechnology/i Parliament and of the Council of 22 September EU Regional binding ndex_en.htm;

2003 on genetically modified food and feed http://www.efsa.europa.eu/en/gmo/gmoapplic ations.htm Regulation (EC) No 1830/2003 of the European Parliament and of the Council of 22 September http://ec.europa.eu/food/plant/gmo/evaluatio 2003 concerning the traceability and labelling of n/index_en.htm; Legally genetically modified organisms and the traceability EU Regional http://ec.europa.eu/food/food/biotechnology/ binding of food and feed products produced from evaluation/docs/gmo_cultivation_report_en.pd genetically modified organisms and amending f

Directive 2001/18/EC Regulation (EC) No 1924/2006 of the European http://ec.europa.eu/food/food/labellingnutriti Legally Parliament and of the Council of 20 December EU Regional on/claims/further_assessment_health_claims_ binding

2006 on nutrition and health claims made on foods en.htm Guidance on the implementation of Regulation No Non- 1924/2006 on nutrition and health claims made on http://ec.europa.eu/food/committees/regulato EU Regional legally foods: Conclusions of the Standing Committee on ry/docs/genet_sum_17012012_en.pdf binding the food chain and animal health Commission Regulation (EC) No 353/2008 of 18 April 2008 establishing implementing rules for applications for authorisation of health claims as Legally http://www.efsa.europa.eu/en/nda/ndaguideli EU Regional provided for in Article 15 of Regulation (EC) No binding nes.htm 1924/2006 of the European Parliament and of the Council

Commission Regulation (EU) No 116/2010 of 9 February 2010 amending Regulation (EC) No Legally EU Regional n/a 1924/2006 of the European Parliament and of the binding

Council with regard to the list of nutrition claims Directive 2009/54/EC of the European Parliament and of the Council of 18 June 2009 on the Legally EU Regional exploitation and marketing of natural mineral binding

waters (recast) Commission Directive 2003/40/EC of 16 May 2003 http://ec.europa.eu/food/food/labellingnutriti

establishing the list, concentration limits and on/water/index_en.htm labelling requirements for the constituents of Legally EU Regional natural mineral waters and the conditions for using binding ozone-enriched air for the treatment of natural

mineral water 36 Commission Regulation (EU) No 115/2010 of 9 February 2010 laying down the conditions for use Legally http://ec.europa.eu/food/food/labellingnutriti EU Regional of activated alumina for the removal of fluoride binding on/water/report_adhod_wg_water_en.pdf

from natural mineral waters and spring waters Directive 2002/46/EC of the European Parliament http://europa.eu/legislation_summaries/consu and of the Council of 10 June 2002 on the Legally EU Regional mers/product_labelling_and_packaging/l21102 approximation of the laws of the Member States binding

_en.htm relating to food supplements Commission Directive 2006/37/EC of 30 March 2006 amending Annex II to Directive 2002/46/EC of Legally EU Regional n/a the European Parliament and of the Council as binding

regards the inclusion of certain substances Commission Regulation (EC) No 1170/2009 of 30 November 2009 amending Directive 2002/46/EC of the European Parliament and of Council and Legally Regulation (EC) No 1925/2006 of the European EU Regional n/a binding Parliament and of the Council as regards the lists of vitamin and minerals and their forms that can be added to foods, including food supplements Commission Regulation (EU) No 1161/2011 of 14 November 2011 amending Directive 2002/46/EC of the European Parliament and of the Council, Legally http://ec.europa.eu/food/food/labellingnutriti Regulation (EC) No 1925/2006 of the European EU Regional

binding on/supplements/index_en.htm Parliament and of the Council and Commission Regulation (EC) No 953/2009 as regards the lists of

mineral substances that can be added to foods Regulation (EC) No 1137/2008 of the European Parliament and of the Council of 22 October 2008 http://ec.europa.eu/food/food/labellingnutriti adapting a number of instruments subject to the Legally EU Regional on/supplements/documents/2007_A540169_st procedure laid down in Article 251 of the Treaty to binding

udy_other_substances.pdf Council Decision 1999/468/EC, with regard to the

regulatory procedure with scrutiny Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December Legally http://ec.europa.eu/food/food/labellingnutriti EU Regional

2006 on the addition of vitamins and minerals and binding on/vitamins/index_en.htm

of certain other substances to foods Regulation (EC) No 108/2008 of the European Parliament and of the Council of 15 January 2008 Legally amending Regulation (EC) No 1925/2006 on the EU Regional n/a binding addition of vitamins and minerals and of certain

other substances to foods

37 Commission Implementing Regulation (EU) No 307/2012 of 11 April 2012 establishing http://ec.europa.eu/food/food/labellingnutriti implementing rules for the application of Article 8 Legally on/vitamins/sa_yohimbe_en.pdf; of Regulation (EC) No 1925/2006 of the European EU Regional binding http://ec.europa.eu/food/food/labellingnutriti Parliament and of the Council on the addition of on/vitamins/sa_ephedra_supp_en.pdf vitamins and minerals and of certain other

substances to foods Commission Implementing Regulation (EU) No 489/2012 of 8 June 2012 establishing implementing rules for the application of Article 16 Legally of Regulation (EC) No 1925/2006 of the European EU Regional n/a binding Parliament and of the Council on the addition of vitamins and minerals and certain other

substances to foods Proposal 2011/0156 (COD) for a Regulation of the http://ec.europa.eu/food/food/labellingnutriti European Parliament and of the Council on food Legally EU Regional on/nutritional/docs/impact_assessment_en.pd intended for infants and young children and on binding

f food for special medical purposes Directive 2009/39/EC of the European Parliament http://ec.europa.eu/food/food/labellingnutriti Legally and of the Council of 6 May 2009 on foodstuffs EU Regional on/nutritional/docs/sanco_11224_2011_rev5_ binding intended for particular nutritional uses (recast) en.pdf Commission Directive 2006/141/EC of 22 Legally http://ec.europa.eu/food/fvo/specialreports/2 December 2006 on infant formulae and follow-on EU Regional

binding 010_8768_en.pdf formulae and amending Directive 1999/21/EC WHO Non- Development of a Global Strategy on Infant and Regional http://www.who.int/nutrition/publications/im Global legally

Young Child Feeding Office for plementing_gs_iycf_report_content.pdf binding Europe Commission Directive 2006/125/EC of 5 December Legally http://ec.europa.eu/food/food/labellingnutriti 2006 on processed cereal-based foods and baby EU Regional

binding on/children/baby_food_en.htm foods for infants and young children Commission Regulation (EC) No 953/2009 of 13 http://ec.europa.eu/food/food/labellingnutriti October 2009 on substances that may be added for Legally EU Regional on/nutritional/docs/impact_assessment_en.pd specific nutritional purposes in foods for particular binding

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for a two-year period

38 Commission Regulation (EC) No 1243/2008 of 12 http://eur- December 2008 amending Annexes III and VI to Legally lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ EU Regional Directive 2006/141/EC as regards compositional binding :L:2008:335:0025:0027:EN:PDF

requirements for certain infant formulae Council Resolution 92/C 172/01 of 18 June 1992 on Non- the marketing of breast-milk substitutes in third EU Regional legally n/a

countries by Community-based manufacturers binding Council Directive 92/52/EEC of 18 June 1992 on Legally infant formulae and follow-on formulae intended EU Regional n/a binding for export to third countries Commission Directive 1999/50/EC of 25 May 1999 Legally amending Directive 91/321/EEC on infant formulae EU Regional n/a binding and follow-on formulae Commission Directive 2006/125/EC of 5 December Legally 2006 on processed cereal-based foods and baby EU Regional n/a binding foods for infants and young children Commission Directive 1999/39/EC of 6 May 1999 amending Directive 96/5/EC on processed cereal- Legally EU Regional n/a based foods and baby foods for infants and young binding

children Commission Directive 96/8/EC of 26 February 1996 Legally on foods intended for use in energy-restricted EU Regional n/a binding diets for weight reduction Commission Regulation (EC) No 953/2009 of 13 October 2009 on substances that may be added for Legally EU Regional n/a specific nutritional purposes in foods for particular binding

nutritional uses Commission Directive 2007/29/EC of 30 May 2007 amending Directive 96/8/EC as regards labelling, Legally EU Regional n/a advertising or presenting foods intended for use in binding

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1999 on dietary foods for special medical purposes binding

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39 Commission Regulation (EC) No 41/2009 of 20 January 2009 concerning the composition and Legally EU Regional n/a labelling of foodstuffs suitable for people binding

intolerant to gluten

Report COM/2008/0392 final from the Commission Non- to the European Parliament and the Council on EU Regional legally n/a foods for persons suffering from carbohydrate binding metabolism disorders Council Directive 89/398/EEC of 3 May 1989 on the http://eur- approximation of the laws of Member States Legally EU Regional lex.europa.eu/LexUriServ/LexUriServ.do?uri=CE relating to foodstuffs intended for particular binding

LEX:52008DC0393:EN:NOT nutritional uses Council Directives concerning Legislation on Food Legally http://ec.europa.eu/food/food/biosafety/hygie EU Regional

Hygiene binding nelegislation/docs/report_act_part1_en.pdf http://ec.europa.eu/food/food/biosafety/hygie Regulation (EC) 852/2004 of the European Legally nelegislation/guidance_doc_852-2004_en.pdf; Parliament and of the Council of 29 April 2004 on EU Regional binding http://ec.europa.eu/food/food/biosafety/hygie the hygiene of foodstuffs nelegislation/guidance_doc_haccp_en.pdf Regulation (EC) 853/2004 of the European Parliament and of the Council of 29 April 2004 Legally http://ec.europa.eu/food/food/biosafety/hygie EU Regional laying down specific hygiene rules for food of binding nelegislation/guidance_doc_853-2004_en.pdf

animal origin Regulation (EC) No 854/2004 of the European Parliament and of the Council of 29 April 2004 http://europa.eu/legislation_summaries/food_ Legally laying down specific rules for the organisation of EU Regional safety/veterinary_checks_and_food_hygiene/f binding official controls on products of animal origin 84003_en.htm

intended for human consumption Directive 2004/41/EC of the European Parliament and of the Council of 21 April 2004 repealing certain Directives concerning food hygiene and health conditions for the production and placing Legally EU Regional n/a on the market of certain products of animal origin binding intended for human consumption and amending Council Directives 89/662/EEC and 92/118/EEC and

Council Decision 95/408/EC, 21 April 2004 Regulation (EC) No 882/2004 of the European http://ec.europa.eu/food/international/trade/i Parliament and of the Council of 29 April 2004 on Legally nterpretation_imports.pdf; http://eur- official controls performed to ensure the EU Regional binding lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ verification of compliance with feed and food law, :C:2011:271:0009:0017:EN:PDF animal health and animal welfare rules

40 Council Directive 2002/99/EC of 16 December 2002 laying down the animal health rules governing the Legally production, processing, distribution and EU Regional n/a binding introduction of products of animal origin for human consumption Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member Legally EU Regional n/a States concerning food additives authorised for use binding

in foodstuffs intended for human consumption European Parliament and Council Directive 94/34/EC of 30 June 1994 amending Directive 89/107/EEC on the approximation of the laws of Legally EU Regional n/a Member States concerning food additives binding authorised for use in foodstuffs intended for

human consumption Directive 2006/52/EC of the European Parliament and of the Council of 5 July 2006 amending Legally Directive 95/2/EC on food additives other than EU Regional n/a binding colours and sweeteners and Directive 94/35/EC on

sweeteners for use in foodstuffs Legally

Legislation on authorised colourants EU Regional n/a binding Legally

Legislation on authorised colouring matters EU Regional n/a binding http://eur- lex.europa.eu/smartapi/cgi/sga_doc?smartapi! Legally

Legislation on authorised sweeteners EU Regional celexapi!prod!DocNumber&type_doc=COMfina binding l&an_doc=2007&nu_doc=0418&model=guichet

i&lg=en Legislation on additives other than authorised Legally EU Regional n/a colours and sweeteners binding Legislation on verification of purity criteria for Legally EU Regional n/a certain authorised additives binding Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December Legally 2008 establishing a common authorisation EU Regional n/a binding procedure for food additives, food enzymes and

food flavourings

41 Regulation (EC) No 1332/2008 of the European Parliament and of the Council of 16 December 2008 on food enzymes and amending Council Legally Directive 83/417/EEC, Council Regulation (EC) No EU Regional n/a binding 1493/1999, Directive 2000/13/EC, Council Directive 2001/112/EC and Regulation (EC) No

258/97 Regulation (EC) No 1333/2008 of the European Legally Parliament and of the Council of 16 December EU Regional n/a binding

2008 on food additives Regulation (EC) No 1334/2008 of the European Parliament and of the Council of 16 December 2008 on flavouring and certain food ingredients Legally with flavouring properties amending Council EU Regional n/a binding Regulation (EEC) No 1601/91, Regulations (EC) No 2232/96 and (EC) No 110/2008 and Directive

2000/13/EC Commission Directive 2008/5/EC of 30 January 2008 concerning the compulsory indication on the Legally labelling of certain foodstuffs of particulars other EU Regional n/a binding than those provided for in Directive 2000/13/EC of

the European Parliament and of the Council European Parliament and Council Directive 94/35/EC of 30 June 1994 on sweeteners for use in Legally EU Regional n/a foodstuffs, amended by Directives 96/83/EC and binding

2003/115/EC and Directive 2006/52/EC Report COM/2001/0542 final from the Commission Non- on Dietary Food Additive Intake in the European EU Regional legally n/a

Union binding Council Regulation (EEC) No 315/93 of 8 February Legally 1993 laying down Community procedures for EU Regional n/a binding contaminants in food Commission Regulation (EC) No 1881/2006 of 19 Legally December 2006 setting maximum levels for certain EU Regional n/a binding contaminants in foodstuffs Commission Recommendation of 28 March 2007 Non- http://www.efsa.europa.eu/en/scdocs/doc/17 on the monitoring of the presence of furan in EU Regional legally

02.pdf foodstuffs binding Commission Recommendation of 2 June 2010 on Non- http://ec.europa.eu/food/food/chemicalsafety EU Regional the monitoring of acrylamide levels in food legally /contaminants/acryl_database_en.htm

42 binding

Commission Recommendation 2010/133/EU of 2 March 2010 on the prevention and reduction of Non- ethyl carbamate contamination in stone fruit EU Regional legally n/a spirits and stone fruit marc spirits and on the binding monitoring of ethyl carbamate levels in these

beverages Commission Recommendation of 17 March 2010 Non- on the monitoring of perfluoroalkylated EU Regional legally n/a

substances in food binding http://eur- lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ Legally Salmonella and Food-borne Diseases Legislation EU Regional :L:1999:210:0012:0012:EN:PDF; http://eur- binding lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ :L:1993:062:0038:0048:EN:PDF Commission Directive 98/15/EC of 27 February http://eur- 1998 amending Council Directive 91/271/EEC with Legally EU Regional lex.europa.eu/LexUriServ/LexUriServ.do?uri=CE respect to certain requirements established in binding

LEX:52001DC0452:EN:HTML

Annex I thereof http://ec.europa.eu/food/food/chemicalsafety Legally

Food contaminants EU Regional /contaminants/fs_contaminants_final_web_en. binding

pdf Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs Legally EU Regional n/a of animal origin, repealing Council Regulation (EEC) binding No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European

Parliament and of the Council Commission Decision 97/747/EC of 27 October 1997 fixing the levels and frequencies of sampling Legally http://ec.europa.eu/food/food/chemicalsafety provided for by Council Directive 96/23/EC for the EU Regional

binding /residues/workdoc_2010_en.pdf monitoring of certain substances and residues

thereof in certain animal products

43 Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and http://ec.europa.eu/food/food/chemicalsafety residues thereof in live animals and animal Legally /residues/workdoc_2010_en.pdf; http://eur- EU Regional products and repealing Directives 85/358/EEC and binding lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ 846/469/EEC and Decisions 89/187/EEC and :L:2011:070:0040:0046:EN:PDF

91/664/EEC Regulation (EC) No 396/2005 of the European http://eur- Parliament and of the Council of 23 February 2005 Legally lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ on maximum residue levels of pesticides in or on EU Regional binding :L:2005:070:0001:0016:en:PDF food and feed of plant and animal origin and

amending Council Directive 91/414/EEC Regulation (EC) No 299/2008 of the European Parliament and of the Council of 11 March 2008 amending Regulation (EC) No 396/2005 on Legally maximum residue levels of pesticides in or on food EU Regional n/a binding and feed of plant and animal origin, as regards the implementing powers conferred on the

Commission Commission Regulation (EU) No 600/2010 of 8 July 2010 amending Annex I to Regulation (EC) No 396/2005 of the European Parliament and of the Legally EU Regional n/a Council as regards additions and modification of binding the examples of related varieties or other products

to which the same MRL applies Commission Regulation (EC) No 178/2006 of 1 February 2006 amending Regulation (EC) No 396/2005 of the European Parliament and of the Legally EU Regional n/a Council to establish Annex I listing the food and binding feed products to which maximum levels for

pesticide residues apply Commission Regulation (EU) No 473/2012 of 04 June 2012 amending Annex III to Regulation (EC) Legally No 396/2005 of the European Parliament and of EU Regional n/a binding the Council as regards maximum residue levels for

spinetoram (XDE-175) in or on certain products

44 Commission Regulation (EU) No 441/2012 of 24 May 2012 amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for bifenazate, bifenthrin, boscalid, cadusafos, Legally chlorantraniliprole, chlorothalonil, clothianidin, EU Regional n/a binding cyproconazole, deltamethrin, dicamba, difenoconazole, dinocap, etoxazole, fenpyroximate, flubendiamide, fludioxonil, glyphosate, metalaxyl-M, meptyldinocap, novaluron, thiamethoxam, and

triazophos in or on certain products

Commission Regulation (EU) No 322/2012 of 16 April 2012 amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Legally EU Regional n/a Council as regards maximum residue levels for binding clopyralid, dimethomorph, fenpyrazamine, folpet and

pendimethalin in or on certain products

Commission Regulation (EU) No 270/2012 of 26 March 2012 amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of Legally the Council as regards maximum residue levels for EU Regional n/a binding amidosulfuron, azoxystrobin, bentazone, bixafen, cyproconazole, fluopyram, imazapic, malathion,

propiconazole and spinosad in or on certain products Commission Regulation (EU) No 978/2011 of 3 October 2011 amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for acetamiprid, biphenyl, captan, Legally chlorantraniliprole, cyflufenamid, cymoxanil, EU Regional n/a binding dichlorprop-P, difenoconazole, dimethomorph, dithiocarbamates, epoxiconazole, ethephon, flutriafol, fluxapyroxad, isopyrazam, propamocarb, pyraclostrobin, pyrimethanil and spirotetramat in or

on certain products Commission Regulation (EU) No 813/2011 of 11 August 2011 amending Annexes II and III to Regulation (EC) No 396/2005 of the European Legally EU Regional n/a Parliament and of the Council as regards maximum binding residue levels for acequinocyl, emamectin benzoate, ethametsulfuron- methyl,

45 flubendiamide, fludioxonil, kresoxim-methyl, methoxyf(e)nozide, Novaluron, thiacloprid and

trifloxystrobin in or on certain products Commission Regulation (EU) No 812/2011 of 10 August 2011 amending Annex III to Regulation (EC) No 396/2005 of the European Parliament and of Legally the Council as regards maximum residue levels for EU Regional n/a binding dimethomorph, fluopicolide, mandipropamid, metrafenone, nicotine and spirotetramat in or on

certain products Commission Regulation (EU) No 559/2011 of 7 June 2011 amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum Legally EU Regional n/a residue levels for captan, carbendazim, binding cyromazine, ethephon, fenamiphos, thiophanate- methyl, triasulfuron and triticonazole in or on

certain products Commission Regulation (EU) No 524/2011 of 26 May 2011 amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum Legally EU Regional n/a residue levels for biphenyl, deltamethrin, binding ethofumesate, isopyrazam, propiconazole, pymetrozine, pyrimethanil and tebuconazole in or

on certain products Commission Regulation (EU) No 520/2011 of 25 May 2011 amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for benalaxyl, boscalid, buprofezin, Legally EU Regional n/a carbofuran, carbosulfan, cypermethrin, binding fluopicolide, hexythiazox, indoxacarb, metaflumizone, methoxy- fenozide, paraquat, prochloraz, spirodiclofen, prothioconazole and

zoxamide in or on certain products

46 Commission Regulation (EU) No 508/2011 of 24 May 2011 amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for abamectin, acetamiprid, Legally EU Regional n/a cyprodinil, difenoconazole, dimethomorph, binding fenhexamid, proquinazid, prothioconazole, pyraclostrobin, spirotetramat, thiacloprid, thiamethoxam and trifloxystrobin in or on certain

products Commission Regulation (EU) No 460/2011 of 12 May 2011 amending Annex III to Regulation (EC) No 396/2005 of the European Parliament and of Legally EU Regional n/a the Council as regards the maximum residue level binding for chlorantraniliprole (DPX E-2Y45) in or on

carrots Commission Regulation (EU) No 310/2011 of 28 March 2011 amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum Legally residue levels for aldicarb, bromopropylate, EU Regional n/a binding chlorfenvinphos, endosulfan, EPTC, ethion, fenthion, fomesafen, methabenzthiazuron, methidathion, simazine, tetradifon and triforine in

or on certain products Commission Regulation (EU) No 893/2010 of 8 October 2010 amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum Legally residue levels for acequinocyl, bentazone, EU Regional n/a binding carbendazim, cyfluthrin, fenamidone, fenazaquin, flonicamid, flutriafol, imidacloprid, ioxynil, metconazole, prothioconazole, tebufenozide and

thiophanate-methyl in or on certain products Commission Regulation (EU) No 765/2010 of 25 August 2010 amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum Legally EU Regional n/a residue levels for chlorothalonil, clothianidin, binding difenoconazole, fenhexamid, flubendiamide, nicotine, spirotetramat, thiacloprid and

thiamethoxam in or on certain products 47 Commission Regulation (EU) No 750/2010 of 7 July 2010 amending Annexes II and III to Regulation Legally (EC) No 396/2005 of the European Parliament and EU Regional n/a binding of the Council as regards maximum residue levels

for certain pesticides in or on certain products Commission Regulation (EU) No 459/2010 of 27 May 2010 amending Annexes II, III and IV to Regulation (EC) No 396/2005 of the European Legally EU Regional n/a Parliament and of the Council as regards maximum binding residue levels for certain pesticides in or on certain

products Commission Regulation (EU) No 304/2010 of 9 April 2010 amending Annex II to Regulation (EC) No Legally 396/2005 of the European Parliament and of the EU Regional n/a binding Council as regards maximum residue levels for 2-

phenylphenol in or on certain products Commission Regulation (EC) No 1097/2009 of 16 November 2009 amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels Legally EU Regional n/a for dimethoate, ethephon, fenamiphos, fenarimol, binding methamidophos, methomyl, omethoate, oxydemeton-methyl, procymidone, thiodicarb and

vinclozolin in or on certain products

Commission Regulation (EC) No 1050/2009 of 28 October 2009 amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for azoxystrobin, acetamiprid, Legally EU Regional n/a clomazone, cyflufenamid, emamectin benzoate, binding famoxadone, fenbutatin oxide, flufenoxuron, fluopicolide, indoxacarb, ioxynil, mepanipyrim, prothioconazole, pyridalyl, thiacloprid and

trifloxystrobin in or on certain products

48 Commission Regulation (EC) No 822/2009 of 27 August 2009 amending Annexes II, III and IV to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for azoxystrobin, atrazine, Legally EU Regional n/a chlormequat, cyprodinil, dithiocarbamates, binding fludioxonil, fluroxypyr, indoxacarb, mandipropamid, potassium tri-iodide, spirotetramat, tetraconazole, and thiram in or on

certain products

Commission Regulation (EC) No 256/2009 of 23 March 2009 amending Annexes II and III to Regulation (EC) No 396/2005 of the European Legally EU Regional n/a Parliament and of the Council as regards maximum binding residue levels for azoxystrobin and fludioxonil in or

on certain products

Commission Regulation (EC) No 839/2008 of 30 August 2008 amending Regulation (EC) No 396/2005 of the European Parliament and of the Legally EU Regional n/a Council as regards Annexes II, III and IV on binding maximum residue levels of pesticides in or on

certain products Commission Regulation (EC) No 149/2008 of 29 January 2008 amending Regulation (EC) No 396/2005 of the European Parliament and of the Legally EU Regional n/a Council by establishing Annexes II, III and IV setting binding maximum residue levels for products covered by

Annex I thereto Commission Regulation (EC) No 260/2008 of 18 March 2008 amending Regulation (EC) No 396/2005 of the European Parliament and of the Legally Council by establishing Annex VII listing active EU Regional n/a binding substance/product combinations covered by a derogation as regards post harvest treatments

with a fumigant Directive 98/8/EC of the European Parliament and http://europa.eu/legislation_summaries/food_ Legally of the Council of 16 February 1998 concerning the EU Regional safety/contamination_environmental_factors/l binding placing of biocidal products on the market 21178_en.htm

49 http://ec.europa.eu/governance/impact/plann Legally

EU Plant Health Law EU Regional ed_ia/docs/2013_sanco_002_eu_plant_health_ binding law_en.pdf Legally http://ec.europa.eu/food/plant/propagation/e

Seeds and propagating material EU Regional

binding valuation/index_en.htm http://ec.europa.eu/food/plant/propertyrights

Plant Property Rights EU Regional

/docs/cpvr_evaluation_final_report.pdf International Treaty on Plant Genetic Resources for United Legally

Global http://www.pgrfa.org/gpa/selectcountry.jspx

Food and Agriculture Nations binding Directive 2011/91/EU of the European Parliament http://eur- and of the Council of 13 December 2011 on Legally lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ EU Regional indications or marks identifying the lot to which a binding :L:2011:334:0001:0005:EN:PDF

foodstuff belongs Commission Directive 2010/59/EU of 26 August 2010 amending Directive 2009/32/EC of the European Parliament and of the Council on the Legally EU Regional n/a approximation of the laws of the Member States binding on extraction solvents used in the production of foodstuffs and food ingredients

Commission Regulation (EU) No 257/2010 of 25 March 2010 setting up a programme for the re- evaluation of approved food additives in Legally EU Regional n/a accordance with Regulation (EC) No 1333/2008 of binding the European Parliament and of the Council on

food additives

Commission Regulation (EU) No 375/2010 of 3 May 2010 refusing to authorise a health claim made on Legally foods, other than those referring to the reduction EU Regional n/a binding of disease risk and to children’s development and

health

Commission Regulation (EU) No 382/2010 of 5 May 2010 refusing to authorise certain health claims Legally made on foods, other than those referring to the EU Regional n/a binding reduction of disease risk and to children’s

development and health

50 Commission Regulation (EU) No 383/2010 of 5 May 2010 refusing to authorise a health claim made on Legally foods, other than those referring to the reduction EU Regional n/a binding of disease risk and to children’s development and

health Commission Regulation (EU) No 384/2010 of 5 May 2010 on the authorisation and refusal of Legally authorisation of certain health claims made on EU Regional n/a binding foods and referring to the reduction of disease risk and to children’s development and health Commission Regulation (EU) No 605/2010 of 2 July 2010 laying down animal and public health and veterinary certification conditions for the Legally EU Regional n/a introduction into the European Union of raw milk binding and dairy products intended for human

consumption Commission Regulation (EU) No 957/2010 of 22 October 2010 on the authorisation and refusal of Legally authorisation of certain health claims made on EU Regional n/a binding foods and referring to the reduction of disease risk

and to children’s development and health Commission Regulation (EU) No 958/2010 of 22 October 2010 refusing to authorise a health Legally claim made on foods, other than those referring to EU Regional n/a binding the reduction of disease risk and to children’s

development and health Commission Regulation (EU) No 1161/2010 of 9 December 2010 refusing to authorise a health Legally claim made on foods, other than those referring to EU Regional n/a binding the reduction of disease risk and to children’s

development and health Commission Regulation (EU) No 1162/2010 of 9 December 2010 refusing to authorise certain Legally health claims made on foods and referring to the EU Regional n/a binding reduction of disease risk and to children’s

development and health

51 Commission Decision 2011/73/EU of 2 February 2011 authorising the placing on the market of a mycelial extract from Lentinula edodes (Shiitake Legally EU Regional n/a mushroom) as a novel food ingredient under binding Regulation (EC) No 258/97 of the European Parliament and of the Council Commission Decision 2011/76/EU of 2 February 2011 authorising the placing on the market of a Legally chitin-glucan from Aspergillus niger as a novel food EU Regional n/a binding ingredient under Regulation (EC) No 258/97 of the

European Parliament and of the Council Commission Decision 2011/80/EU of 4 February 2011 authorising the placing on the market of a Legally fish (Sardinops sagax) peptide product as a novel EU Regional n/a binding food ingredient under Regulation (EC) No 258/97

of the European Parliament and of the Council Commission Decision 2011/242/EU of 14 April 2011 on the members of the advisory group on the Legally EU Regional n/a food chain and animal and plant health established binding

by Decision 2004/613/EC Commission Decision 2011/320/EU of 27 May 2011 authorising the placing on the market of Chromium Legally Picolinate as a novel food ingredient under EU Regional n/a binding Regulation (EC) No 258/97 of the European

Parliament and of the Council Commission Implementing Decision 2011/494/EU of 5 August 2011 authorising the placing on the Legally market of phosphated maize starch as a novel food EU Regional n/a binding ingredient under Regulation (EC) No 258/97 of the

European Parliament and of the Council Commission Implementing Decision 2011/497/EU of 9 August 2011 authorising the placing on the Legally market of fermented black bean extract as a novel EU Regional n/a binding food ingredient under Regulation (EC) No 258/97

of the European Parliament and of the Council Commission Implementing Decision 2011/761/EU of 24 November 2011 authorising the placing on the market of flavonoids from Glycyrrhiza glabra L. Legally EU Regional n/a as a novel food ingredient under Regulation (EC) binding No 258/97 of the European Parliament and of the

Council

52 Commission Implementing Decision 2011/762/EU of 24 November 2011 authorising the placing on Legally the market of yeast beta-glucans as a novel food EU Regional n/a binding ingredient under Regulation (EC) No 258/97 of the

European Parliament and of the Council Commission Implementing Decision 2011/882/EU of 21 December 2011 authorising the placing on Legally the market of a novel chewing gum base as a novel EU Regional n/a binding food ingredient under Regulation (EC) No 258/97

of the European Parliament and of the Council Commission Decision 2011/C 271/05 of 12 http://eur- September 2011 on the financing for the year 2011 Legally EU Regional lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ of several measures necessary to ensure the binding

:C:2011:271:0009:0017:EN:PDF application of Regulation (EC) No 882/2004 Commission Regulation (EU) No 10/2011 of 14 Legally January 2011 on plastic materials and articles EU Regional n/a binding intended to come into contact with food Commission Regulation (EU) No 234/2011 of 10 March 2011 implementing Regulation (EC) No 1331/2008 of the European Parliament and of the Legally EU Regional n/a Council establishing a common authorisation binding procedure for food additives, food enzymes and

food flavourings Commission Implementing Regulation (EU) No 844/2011 of 23 August 2011 approving the pre- Legally export checks carried out by Canada on wheat and EU Regional n/a binding wheat flour as regards the presence of ochratoxin

A Commission Regulation (EU) No 1129/2011 of 11 November 2011 amending Annex II to Regulation Legally (EC) No 1333/2008 of the European Parliament EU Regional n/a binding and of the Council by establishing a Union list of

food additives

Commission Regulation (EU) No 1160/2011 of 14 November 2011 on the authorisation and refusal Legally EU Regional n/a of authorisation of certain health claims made on binding

foods and referring to the reduction of disease risk

53 Commission Regulation (EU) No 1170/2011 of 16 November 2011 refusing to authorise certain Legally EU Regional n/a health claims made on foods and referring to the binding

reduction of disease risk

Commission Regulation (EU) No 1171/2011 of 16 November 2011 refusing to authorise certain Legally health claims made on foods, other than those EU Regional n/a binding referring to the reduction of disease risk and to

children’s development and health

Commission Implementing Regulation (EU) No 1274/2011 of 7 December 2011 concerning a coordinated multiannual control programme of the Union for 2012, 2013 and 2014 to ensure Legally EU Regional n/a compliance with maximum residue levels of binding pesticides and to assess the consumer exposure to pesticide residues in and on food of plant and animal origin Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications for food Legally additives listed in Annexes II and III to Regulation EU Regional n/a binding (EC) No 1333/2008 of the European Parliament

and of the Council Commission Implementing Regulation (EU) No 307/2012 of 11 April 2012 establishing implementing rules for the application of Article 8 Legally of Regulation (EC) No 1925/2006 of the European EU Regional n/a binding Parliament and of the Council on the addition of vitamins and minerals and of certain other substances to foods Commission Regulation (EU) No 378/2012 of 3 May 2012 refusing to authorise certain health claims Legally made on foods and referring to the reduction of EU Regional n/a binding disease risk and to children’s development and

health Commission Regulation (EU) No 379/2012 of 3 May 2012 refusing to authorise certain health claims Legally made on foods, other than those referring to the EU Regional n/a binding reduction of disease risk and to children’s

development and health

54 Commission Regulation (EU) No 432/2012 of 16 May 2012 establishing a list of permitted health Legally claims made on foods, other than those referring EU Regional n/a binding to the reduction of disease risk and to children’s

development and health The WTO Agreement on the Application of Sanitary Legally http://www.wto.org/english/tratop_e/monitor WTO Global

and Phytosanitary Measures (SPS Agreement) binding _e/monitor_e.htm Non- The new Animal Health Strategy (2007-2013): http://ec.europa.eu/food/animal/diseases/stra EU Regional legally

“prevention is better than cure” tegy/archives/final_report_en.htm binding Council Recommendation 2009/C 151/01 of 9 June Non- http://www.ecdc.europa.eu/en/healthtopics/H 2009 on patient safety, including the prevention EU Regional legally ealth care-

and control of healthcare associated infections binding associated_infections/Pages/index.aspx Proposal COM(2008) 837 final/2 for a Council Non- Recommendation on patient safety, including the EU Regional legally n/a prevention and control of health care associated binding

infections Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, Legally EU Regional testing, processing, storage and distribution of binding human blood and blood components and http://ec.europa.eu/health/blood_tissues_orga

amending Directive 2001/83/EC

ns/docs/blood_reportdonation_en.pdf; Commission Implementing Directive 2011/38/EU http://eur- of 11 April 2011 amending Annex V to Directive Legally lex.europa.eu/Notice.do?mode=dbl&lang=en&i 2004/33/EC with regards to maximum pH values EU Regional binding hmlang=en&lng1=en,en&lng2=cs,da,de,el,en,es D. Others D. for platelets concentrates at the end of the shelf ,et,fi,fr,hu,it,lt,lv,mt,nl,pl,pt,sk,sl,sv,&val=42854

life 0:cs&page=; Commission Directive 2009/135/EC of 3 November http://ec.europa.eu/health/ph_threats/human 2009 allowing temporary derogations to certain _substance/documents/blood_com_0217_en.p eligibility criteria for whole blood and blood Legally df; components donors laid down in Annex III to EU Regional binding http://ec.europa.eu/health/ph_risk/committee Directive 2004/33/EC in the context of a risk of s/scmp/documents/out49_en.pdf; shortage caused by the Influenza A(H1N1) http://www.coe.int/t/dg3/health/publications_

pandemic en.asp Commission Directive 2005/62/EC of 30 September 2005 implementing Directive 2002/98/EC of the Legally European Parliament and of the Council as regards EU Regional binding Community standards and specifications relating to

a quality system for blood establishments

55 Commission Directive 2005/61/EC of 30 September 2005 implementing Directive 2002/98/EC of the Legally European Parliament and of the Council as regards EU Regional binding traceability requirements and notification of

serious adverse reactions and events Commission Directive 2004/33/EC of 22 March 2004 implementing Directive 2002/98/EC of the Legally European Parliament and of the Council as regards EU Regional binding certain technical requirements for blood and blood

components Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, Legally EU Regional testing, processing, storage and distribution of binding human blood and blood components and

amending Directive 2001/83/EC Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Legally EU Regional Community code relating to medicinal products for binding

human use European Parliament legislative resolution COM(2000) 816 on the proposal for a European Parliament and Council directive setting standards Non- of quality and safety for the collection, testing, EU Regional legally processing, storage, and distribution of human binding blood and blood components and amending

Council Directive 89/381/EEC Directive 2000/70/EC of the European Parliament and of the Council of 16 November 2000 amending Legally Council Directive 93/42/EEC as regards medical EU Regional binding devices incorporating stable derivates of human

blood or human plasma http://www.who.int/bloodsafety/global_datab Non- ase/GDBS_Summary_Report_2011.pdf;

Global database on blood safety WHO Global legally http://www.who.int/bloodsafety/global_datab binding ase/tools/en/index.html Corrigendum to Directive 2010/45/EU of the European Parliament and of the Council of 7 July Legally EU Regional n/a 2010 on standards of quality and safety of human binding

organs intended for transplantation

56 Directive 2010/45/EU of the European Parliament and of the Council of 7 July 2010 on standards of Legally EU Regional n/a quality and safety of human organs intended for binding

transplantation Proposal COM(2008) 819 final for a Directive of the European Parliament and of the Council on Legally EU Regional standards of quality and safety of human organs binding http://ec.europa.eu/health/ph_threats/human intended for transplantation

_substance/oc_organs/docs/impact_en.pdf Action plan on Organ Donation and Non- Transplantation (2009–2015): Strengthened EU Regional legally

Cooperation between Member States binding European Parliament Resolution 2007/2210 of 22 Non- April 2008 on organ donation and transplantation: EU Regional legally n/a Policy actions at EU level binding Organ donation and transplantation: Policy options Non- at EU level – Consultation document of 27 June EU Regional legally n/a 2006 binding Commission Decision 2010/453/EU of 3 August http://ec.europa.eu/health/blood_tissues_orga 2010 establishing guidelines concerning the ns/docs/tissues_voluntary_report_en.pdf; conditions of inspections and control measures, Legally http://eur- and on the training and qualification of officials, in EU Regional binding lex.europa.eu/smartapi/cgi/sga_doc?smartapi! the field of human tissues and cells provided for in celexplus!prod!DocNumber&lg=EN&type_doc= Directive 2004/23/EC of the European Parliament COMfinal&an_doc=2011&nu_doc=352; and of the Council http://ec.europa.eu/health/ph_threats/human Commission Directive 2006/86/EC of 24 October _substance/survey_tissues.pdf; 2006 implementing Directive 2004/23/EC of the http://ec.europa.eu/health/archive/ph_threats European Parliament and of the Council as regards /human_substance/documents/tissues_frep_e traceability requirements, notification of serious Legally EU Regional n.pdf; adverse reactions and events and certain technical binding http://ec.europa.eu/health/blood_tissues_orga requirements for the coding, processing, ns/docs/study_eshre_en.pdf; preservation, storage and distribution of human http://ec.europa.eu/health/blood_tissues_orga tissues and cells ns/key_documents/index_en.htm; Commission Directive 2006/17/EC of 8 February http://ec.europa.eu/bepa/european-group- 2006 implementing Directive 2004/23/EC of the ethics/docs/publ_op19_en.pdf; European Parliament and of the Council as regards Legally http://www.coe.int/t/dg3/health/Source/Guid EU Regional certain technical requirements for the donation, binding eSecurity2_en.pdf; procurement and testing of human tissues and cells

57 Directive 2004/23/EC of the European Parliament https://wcd.coe.int/com.instranet.InstraServlet and of the Council of 31 March 2004 on setting ?command=com.instranet.CmdBlobGet&Instra Legally standards of quality and safety for the donation, EU Regional netImage=533950&SecMode=1&DocId=508796 binding procurement, testing, processing, preservation, &Usage=2 storage and distribution of human tissues and cells European Parliament legislative resolution 10133/3/2003 – C5-0416/2003 – 2002/0128(COD) on the Council common position adopting a Non- European Parliament and Council directive on EU Regional legally setting standards of quality and safety for the binding donation, procurement, testing, processing, preservation, storage and distribution of human

tissues and cells Opinion of the European Economic and Social Committee on the “Proposal for a Directive of the European Parliament and of the Council setting Legally standards of quality and safety for the donation, EU Regional binding procurement, testing, processing, storage, and distribution of human tissues and cells”

(COM(2002) 319 final – 2002/0128 (COD)) Non- Consensus Statement of the Amsterdam Forum on WHO Global legally n/a the Care of the Live Kidney Donor binding Non- WHO Guiding Principles on Human Cell, Tissue and WHO Global legally n/a

Organ Transplantation binding http://www.who.int/transplantation/tra_song/ en/index.html; http://www.who.int/transplantation/tra_notify Non- /en/index.html; WHO Transplantation Documentation WHO Global legally http://www.who.int/entity/transplantation/act binding ivities/ReportGlossaryMeeting.pdf; http://www.who.int/transplantation/ReportOtt awaCTTx.pdf Non- Global Glossary of Terms and Definitions on http://www.who.int/entity/transplantation/act WHO Global legally

Donation and Transplantation ivities/ReportGlossaryMeeting.pdf binding Non- Xenotransplantation – Guidance on Infectious https://extranet.who.int/iris/restricted/bitstrea WHO Global legally

Disease Prevention and Management m/10665/65511/1/WHO_EMC_ZOO_98.1.pdf binding

58 WHO Guidance on Xenogeneic Infection/Disease Non- Surveillance and Response: A Strategy for WHO Global legally n/a

International Cooperation and Coordination binding Non-

Quality Risk Management EU Regional legally n/a binding Non- http://ecologic.eu/download/projekte/1850-

Pharmaceuticals in Drinking-water WHO Global legally 1899/1878/knappe_d31_state_of_art_policy.p

binding df Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Legally EU Regional n/a Community code relating to medicinal products for binding

human use Non- Guideline on the Environmental Risk Assessment of EU Regional legally n/a

Medicinal Products for Human Use binding Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Legally EU Regional n/a Directive 2001/83/EC on the Community code binding

relating to medicinal products for human use Council Directive 87/357/EEC of 25 June 1987 on the approximation of the laws of the Member Legally States concerning products which, appearing to be EU Regional n/a binding other than they are, endanger the health or safety

of consumers Directive 2001/95/EC of the European Parliament Legally http://ec.europa.eu/consumers/safety/prod_le and of the Council of 3 December 2001 on general EU Regional

binding gis/docs/report_impl_gpsd_en.pdf product safety Commission Decision 2008/329/EC of 21 April 2008 requiring Member States to ensure that magnetic Legally http://ec.europa.eu/consumers/safety/prod_le toys placed or made available on the market EU Regional

binding gis/index_en.htm#other display a warning about the health and safety risks they pose Directive 2009/48/EC of the European Parliament Legally and of the Council of 18 June 2009 on the safety of EU Regional n/a binding toys Council Directive 88/378/EEC of 3 May 1988 on the Legally approximation of the laws of the Member States EU Regional n/a binding concerning the safety of toys

59 Council Directive 89/686/EEC of 21 December 1989 Legally on the approximation of the laws of the Member EU Regional n/a binding States relating to personal protective equipment Directive 2006/42/EC of the European Parliament Legally and of the Council of 17 May 2006 on machinery, EU Regional n/a binding and amending Directive 95/16/EC

Directive 2000/14/EC of the European Parliament and of the Council of 8 May 2000 on the Legally approximation of the laws of the Member States EU Regional n/a binding relating to the noise emission in the environment

by equipment for use outdoors

Directive 97/68/EC of the European Parliament and of the Council of 16 December 1997 on the approximation of the laws of the Member States Legally relating to measures against the emission of EU Regional n/a binding gaseous and particulate pollutants from internal combustion engines to be installed in non-road

mobile machinery Council Directive 76/768/EEC of 27 July 1976 on Legally http://ec.europa.eu/consumers/sectors/cosme the approximation of the laws of the Member EU Regional

binding tics/documents/guidelines/index_en.htm

States relating to cosmetic products Non- Measuring Errors and Adverse Events in Health EU Regional legally n/a

Care binding Non-

WHO Guidelines on HIV/AIDS (2011–2012) WHO Global legally n/a binding Diarrhoea treatment guidelines including new Non- recommendations for the use of ORS and zinc WHO Global legally n/a supplementation for clinic-based healthcare binding workers

60 EPHO 4: Health promotion, including action to address social determinants and health inequity Level: global, Evaluation notes (monitoring and assessment Lead Legal EPHO subdivision Title of instrument or tool with hyperlink regional, reports; activity reports; expected outputs; organization status national or countries implementation; transparency) local Proposal COD/2008/0256 for a Directive of the European Parliament and of the Council amending, as regards information to the general public on Legally EU Regional n/a medicinal products subject to medical prescription, binding Directive 2001/83/EC on the Community code

relating to medicinal products for human use Non-

Public health developments ECDC Regional legally n/a binding Non- http://urbact.eu/fileadmin/Projects/Building_H of communities Building Healthy Communities 2011 EU Regional legally ealthy_Communities__BHC_/documents_medi

binding a/Final_Report_bhc_saved.pdf Non-

Risk communication ECDC n/a legally n/a

A. Building and strengthening the resilience resilience the strengthening and Building A. binding http://www.who.int/fctc/implementation/reso Legally urces/en/;

Framework Convention on Tobacco Control WHO Global

binding http://www.who.int/fctc/implementation/nee ds/en/

Council Recommendation 2003/54/EC of 2 Legally December 2002 on the prevention of smoking and EU Regional n/a

groups at increased increased at sub groups binding

on initiatives to improve tobacco control

Legally http://ec.europa.eu/health/tobacco/indicators

EU Directives on tobacco control EU Regional

binding /index_en.htm Directive 2001/37/EC of the European Parliament and of the Council of 5 June 2001 on the http://ec.europa.eu/health/tobacco/events/ind

risk of negative health outcomes approximation of the laws, regulations and Legally ex_en.htm#anchor; EU Regional administrative provisions of the Member States binding http://ec.europa.eu/health/tobacco/indicators B. Health promotion activities targeting the concerning the manufacture, presentation and sale /index_en.htm

well aswell targeting vulnerable population at large through a gradient approach, as as approach, gradient a through large at population of tobacco products

61 Directive 2003/33/EC of the European Parliament and of the Council of 26 May 2003 on the approximation of the laws, regulations and Legally WHO Global administrative provisions of the Member States binding relating to the advertising and sponsorship of

tobacco products Council Directive 2010/12/EU of 16 February 2010 amending Directives 92/79/EEC, 92/80/EEC and Legally 95/59/EC on the structure and rates of excise duty EU Regional binding applied on manufactured tobacco and Directive

2008/118/EC http://mdgs.un.org/unsd/mdg/Resources/Stati c/Products/GAResolutions/65/a_65_L_1_En.pd f; http://www.mdgmonitor.org/index.cfm; http://www.un.org/millenniumgoals/pdf/(2011 Convention against illicit traffic in narcotic drugs United Legally Global E)_MDReport2011_ProgressChart.pdf; and psychotropic substances Nations binding http://www.un.org/millenniumgoals/11_MDG %20Report_EN.pdf; http://www.unodc.org/unodc/en/data-and- analysis/WDR-2011.html Non- United http://www.unaids.org/en/targetsandcommit

2011 Political Declaration on HIV/AIDS Global legally

Nations ments/ binding Non- Moscow Declaration: commitment to action, way WHO Global legally n/a forward binding Regional Committee resolution EUR/RC61/R4: Non- http://www.euro.who.int/__data/assets/pdf_fi European action plan to reduce the harmful use of WHO Regional legally

le/0003/149160/RC61_Pres_Galea_alcohol.pdf alcohol 2012–2020 binding Non- Global Strategy to reduce the harmful use of http://www.who.int/substance_abuse/publicat WHO Global legally alcohol ions/global_alcohol_report/en/index.html binding Non- White Paper A Strategy on Nutrition, Overweight, EU Regional legally n/a and Obesity-related health issues binding Non-

Nutrition Policy databases WHO Regional legally n/a binding Non- http://ec.europa.eu/health/archive/ph_determ EU platform for action on diet, physical activity and EU Regional legally inants/life_style/nutrition/platform/docs/eu_pl health

binding atform_mon-framework_en.pdf 62 Non- http://ec.europa.eu/health/archive/ph_determ EU strategy to support Member States in reducing EU Regional legally inants/life_style/alcohol/documents/alcohol_p alcohol related harm

binding rogress.pdf Non- Meetings of the EU Regulatory Committee for EU Regional legally n/a

Tobacco Control binding http://eur- Non- lex.europa.eu/LexUriServ/site/en/com/2007/co

EU drugs strategy 2005-2012 EU Regional legally m2007_0199en01.pdf; binding http://ec.europa.eu/health/drugs/projects/ind ex_en.htm Directive 2003/33/EC of the European Parliament and of the Council of 26 May 2003 on the http://ec.europa.eu/health/archive/ph_determ approximation of the laws, regulations and Legally EU Regional inants/life_style/tobacco/documents/com_200 administrative provisions of the Member States binding

80520_en.pdf relating to the advertising and sponsorship of

tobacco products Directive 2007/65/EC of the European Parliament and of the Council of 11 December 2007 amending Council Directive 89/552/EEC on the coordination Legally http://ec.europa.eu/avpolicy/info_centre/librar of certain provisions laid down by law, regulation EU Regional

binding y/studies/index_en.htm#promot or administrative action in Member States concerning the pursuit of television broadcasting

activities Directive 2001/37/EC of the European Parliament and of the Council of 5 June 2001 on the approximation of the laws, regulations and Legally http://ec.europa.eu/health/tobacco/docs/toba EU Regional administrative provisions of the Member States binding cco_ia_rand_en.pdf concerning the manufacture, presentation and sale

of tobacco products Green Paper - Improving the mental health of the Non- population: Towards a strategy on mental health EU Regional legally n/a

for the European Union binding Non- http://ec.europa.eu/health/archive/ph_determ EU High Level Conference “Together For Mental EU Regional legally inants/life_style/mental/docs/mh_conference_ Health And Well-Being” Brussels, 13 June 2008 binding mi_en.pdf Non- http://ec.europa.eu/health/mental_health/doc

European Pact for Mental Health and Well-Being EU Regional legally s/mhpact_en.pdf binding Annual epidemiological report on communicable Non- EU Regional n/a diseases in Europe legally

63 binding Directive 2010/13/EU of the European Parliament and of the Council of 10 March 2010 on the http://eur- coordination of certain provisions laid down by Legally EU Regional lex.europa.eu/LexUriServ/LexUriServ.do?uri=S law, regulation or administrative action in Member binding

WD:2012:0125:FIN:EN:PDF States concerning the provision of audiovisual

media services Non- Closing the Gap: Strategies for Action to tackle http://ec.europa.eu/health/social_determinant WHO Global legally

Health Inequalities in Europe s/events/ev_20120619_en.htm binding Communication COM/2009/0567 final from the Commission to the European Parliament, the Non- Council, the European Economic and Social EU Regional legally n/a Committee and the Committee of the Regions - binding Solidarity in health: reducing health inequalities in

the EU

http://www.who.int/nutrition/publications/inf Non- International Code of Marketing of Breast-milk antfeeding/WHO_NUT_98.11/en/index.html; WHO Global legally

Substitutes http://www.who.int/nutrition/publications/inf binding antfeeding/WHO_NUT_96.2/en/index.html

http://www.euro.who.int/en/what-we- WHO Non- publish/abstracts/social-determinants-of- European strategy for child and adolescent health Regional Regional legally health-and-well-being-among-young-people.-

and development Office for binding health-behaviour-in-school-aged-children-hbsc- Europe

study

Non-

Youth Health Initiative EU Regional legally n/a binding

Communication COM(2012) 83 final from the C. Action to address social determinants of health of determinants social address to Action C. Commission to the European Parliament and the Non- http://ec.europa.eu/health/ageing/docs/com_ Council – Taking forward the Strategic EU Regional legally

2012_83_en.pdf Implementation Plan of the European Innovation binding

Partnership on Active and Healthy Ageing

Non- Healthy Ageing: Health Systems – Innovations – EU Regional legally n/a

Consumers binding

64 Principles for the protection of persons with Non- United mental illness and the improvement of mental Global legally n/a Nations health care binding

Non- Rio Political Declaration on Social Determinants of

WHO Global legally http://www.who.int/social_determinants/en/

Health binding

World Health Assembly resolution WHA62.14: Non- Reducing health inequities through action on the WHO Global legally n/a social determinants of health binding http://eur- lex.europa.eu/LexUriServ/LexUriServ.do?uri=CE Directive 2006/54/EC of the European Parliament LEX:72006L0054:EN:NoT; http://eur- and of the Council of 5 July 2006 on the Legally lex.europa.eu/LexUriServ/LexUriServ.do?uri=CE implementation of the principle of equal EU Regional binding LEX:52009DC0409:EN:HTML; opportunities and equal treatment of men and http://ec.europa.eu/justice/gender- women in matters of employment and occupation equality/files/2009reportrecastdirectivefinal_e n.pdf http://europa.eu/legislation_summaries/emplo Non- yment_and_social_policy/equality_between_m A Women’s Charter: A strengthened commitment EU Regional legally en_and_women/em0037_en.htm; towards equality between women and men binding http://ec.europa.eu/social/BlobServlet?docId= 6562&langId=en http://www.coe.int/t/dghl/standardsetting/eq Non- uality/02factsheets/index_en.asp;

Declaration on equality of women and men EU Regional legally http://www.eige.europa.eu/content/women- binding and-men-in-the-eu-facts-and-figures Non- http://eur- Roadmap for equality between women and men EU Regional legally lex.europa.eu/LexUriServ/LexUriServ.do?uri=C

(2006–2010)

binding OM:2006:0092:FIN:EN:PDF WHO Non- Addressing the social determinants of health: the Regional Regional legally n/a urban dimension and the role of local government Office for binding Europe Directive 2003/20/EC of the European Parliament and of the Council of 8 April 2003 amending Legally Council Directive 91/671/EEC on the EU Regional n/a binding approximation of the laws of the Member States relating to compulsory use of safety belts in

65 vehicles of less than 3,5 tonnes

Directive 2005/39/EC of the European Parliament and of the Council of 7 September 2005 amending http://eur- Legally Council Directive 74/408/EEC relating to motor EU Regional lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ binding

vehicles with regard to the seats, their anchorages :L:2005:255:0143:0145:EN:PDF

and head restraints Directive 2005/40/EC of the European Parliament and of the Council of 7 September 2005 amending http://eur- Council Directive 77/541/EEC on the Legally EU Regional lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ approximation of the laws of the Member States binding

:L:2005:255:0146:0148:EN:PDF relating to safety belts and restraint systems of

motor vehicles Directive 2005/41/EC of the European Parliament and of the Council of 7 September 2005 amending http://eur- Council Directive 76/115/EEC on the Legally EU Regional lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ approximation of the laws of the Member States binding

:L:2005:255:0149:0151:EN:PDF relating to anchorages for motor-vehicle safety

belts Regulation 44 – Uniform provisions concerning the http://eur- Legally approval of restraining devices for child occupants UNECE Regional lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ binding

of power driven vehicles (‘child restraint systems’) :L:2005:330:0056:0157:EN:PDF Non- Road safety: Road Safety Action Programme http://ec.europa.eu/transport/road_safety/spe EU Regional legally

(2003–2010) cialist/knowledge/index.htm binding Convention against Torture and Other Cruel, United Legally ]http://www2.ohchr.org/english/law/pdf/cat.p

D. Intersectoral action Global

Inhuman or Degrading Treatment or Punishment Nations binding df Legally http://www2.ohchr.org/english/law/abolition.h

Abolition of Forced Labour Convention ILO Global

binding tm Convention concerning Discrimination in Respect Legally http://www2.ohchr.org/english/law/employme ILO Global

of Employment and Occupation binding nt.htm Convention concerning Minimum Age for Legally http://www2.ohchr.org/english/law/ageconven ILO Global

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binding &subid=A&lang=en

Forms of Child Labour International Convention for the Protection of All United Legally http://treaties.un.org/Pages/Treaties.aspx?id=4 Global

Persons from Enforced Disappearance Nations binding &subid=A&lang=en

66 http://www.ilo.org/dyn/normlex/en/f?p=NOR Convention concerning Forced or Compulsory Legally ILO Global MLEXPUB:12100:0::NO:12100:P12100_ILO_CO

Labour binding

DE:C029 http://treaties.un.org/Pages/Treaties.aspx?id=4 Convention concerning Equal Remuneration for Legally ILO Global &subid=A&lang=en [only for ratification

Men and Women Workers for Work of Equal Value binding

process] International Convention on the Protection of the United Legally http://treaties.un.org/Pages/Treaties.aspx?id=4 Rights of All Migrant Workers and Members of Global

Nations binding &subid=A&lang=en

Their Families Legally http://www.ilo.org/global/standards/maritime-

Maritime Labour Convention ILO Global

binding labour-convention/lang--en/index.htm The Convention on the Elimination of all forms of Legally http://www.un.org/womenwatch/daw/cedaw/ ILO Global

Discrimination against Women binding reports.htm Council Directive 89/391/EEC of 12 June 1989 on http://eur- the introduction of measures to encourage Legally lex.europa.eu/LexUriServ/LexUriServ.do?uri=C EU Regional improvements in the safety and health of workers binding ONSLEG:1989L0391:20081211:EN:PDF

at work The Charter of Fundamental Rights and the Agency Legally EU Regional n/a for Fundamental Rights binding Communication from the Commission to the http://eur- European Parliament, the Council, the European Non- lex.europa.eu/LexUriServ/LexUriServ.do?uri=C Economic and Social Committee and the EU Regional legally OM:2008:0420:FIN:EN:PDF Committee of the Regions - Non-discrimination binding and equal opportunities: A renewed commitment http://eur- Non- lex.europa.eu/LexUriServ/LexUriServ.do?uri=C

EU strategy for sustainable development EU Regional legally OM:2001:0264:FIN:EN:PDF binding

Communication from the Commission to the Non- European Parliament, the Council - European http://ec.europa.eu/health/ageing/docs/com_ EU Regional legally

Innovation Partnership on Active and Healthy 2012_83_en.pdf binding Ageing Strategic Implementation Plan for the European Non- http://ec.europa.eu/research/innovation- Innovation Partnership on Active and Healthy EU Regional legally union/pdf/active-healthy-ageing/steering-

Ageing binding group/implementation_plan.pdf Non- Confronting “Death on Wheels”: Making Roads http://siteresources.worldbank.org/INTECA/Re World Bank Regional legally

Safe in Europe and Central Asia sources/DeathonWheelsWeb.pdf binding Non- http://ec.europa.eu/health/nutrition_physical_

EU Salt Reduction Framework EU Regional legally

activity/docs/salt_report_en.pdf binding 67 European Interim Agreement on Social Security Non- Schemes Relating to Old Age, Invalidity and EU Regional legally n/a

Survivors binding

68 EPHO 5: Disease prevention, including early detection of illness Level: global, Evaluation notes (monitoring and assessment Lead Legal EPHO subdivision Title of instrument or tool with hyperlink regional, reports; activity reports; expected outputs; organization status national countries implementation; transparency) or local Non- WHO global forum for chief nursing and midwifery WHO Global legally n/a

officers: strengthening their role in NCD prevention binding Non- http://ecdc.europa.eu/en/activities/diseasepro

Vaccine-preventable Diseases Programme ECDC Regional legally

grammes/vpd/Pages/phd.aspx binding

Non- http://ec.europa.eu/health/vaccination/hpv/in

Vaccines against cervical cancer EU Regional legally

dex_en.htm binding Non- Vaccination strategies against pandemic (H1N1) EU Regional legally n/a

2009 binding Non- Council Recommendation 2009/1019/EU of 22 EU Regional legally n/a A. Primary prevention Primary A. December 2009 on seasonal influenza vaccination binding Non- http://www.ema.europa.eu/ema/index.jsp?cur Vaccination schedules ECDC Regional legally l=pages/medicines/landing/epar_search.jsp&m

binding id=WC0b01ac058001d124 Communication COM(2006) 328 final from the Non- Commission to the European Parliament and the EU Regional legally n/a

Council on Actions for a Safer Europe binding Non- Council Recommendation 2003/878/EC of 2 EU Regional legally n/a

December 2003 on cancer screening binding Non- http://ec.europa.eu/health/major_chronic_dis

Major and chronic diseases: Cancer EU Regional legally revention eases/diseases/cancer/index_en.htm binding Non- http://www.europeristat.com/our-

Screening and genetics: Prenatal screening EU Regional legally publications/european-perinatal-health-

binding report.html Non- B. Secondary p Secondary B.

Reproductive health EU Regional legally n/a binding

69 Communication COM/2009/0291 final of 24 June 2009 from the Commission to the European Non- Parliament, the Council, the European Economic EU Regional legally n/a and Social Committee and the Committee of the binding Regions on Action against Cancer: European

Partnership Non- European guidelines for quality assurance in EU Regional legally n/a

cervical cancer screening and diagnosis binding http://www.wto.org/english/tratop_e/trips_e/ Agreement on Trade-Related Aspects of Legally par6laws_e.htm; WTO Global

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a_docs_e/3_ipc61_e.pdf

Non- European guidelines for the management of EU Regional legally n/a

chronic non-specific low back pain binding revention Non- WHO Treatment Guidelines on chronic non- WHO Global legally n/a

malignant pain in adults: scoping document binding European Convention relating to the Formalities Legally EU Regional n/a C. Tertiary p Tertiary C. required for Patent Applications binding

70 EPHO 6: Assuring governance for health and well-being Level: global, Evaluation notes (monitoring and assessment Lead Legal EPHO subdivision Title of instrument or tool with hyperlink regional, reports; activity reports; expected outputs; organization status national countries implementation; transparency) or local Legally http://www.who.int/governance/eb/who_cons

Constitution of the World Health Organization WHO Global

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being United Legally - Charter of United Nations Global http://unu.edu/ Nations binding Legally

Acquis communautaire EU Regional n/a binding United Legally http://www.ohchr.org/EN/HRBodies/Pages/Uni

Universal Declaration of Human Rights Global

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Disabilities Nations binding /Disabilities_training_17EN.pdf

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Food Assistance Convention Global

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Availability, safety and quality of blood products binding World Health Assembly resolution WHA63.13: Non- Global strategy to reduce the harmful use of WHO Global legally

alcohol binding

World Health Assembly resolution WHA63.14: Non- Marketing of food and non-alcoholic beverages to WHO Global legally

children binding

World Health Assembly resolution WHA63.15: Non- Monitoring of the achievement of the health- WHO Global legally

related Millennium Development Goals binding World Health Assembly resolution WHA63.16: Non- WHO Global Code of Practice on the International WHO Global legally

Recruitment of Health Personnel binding Non- World Health Assembly resolution WHA63.17: WHO Global legally

Birth defects binding Non- World Health Assembly resolution WHA63.18: Viral WHO Global legally details of the implementation of most of these hepatitis binding resolutions are included as separate documents Non- World Health Assembly resolution WHA63.19: (policies, frameworks, strategies, action plans) WHO Global legally

WHO HIV/AIDS strategy for 2011–2015 binding Non- World Health Assembly resolution WHA63.20: WHO Global legally

Chagas disease: control and elimination binding Non- World Health Assembly resolution WHA63.21: WHO Global legally

WHO’s role and responsibilities in health research binding Non- World Health Assembly resolution WHA63.22: WHO Global legally

Human organ and tissue transplantation binding

87 Non- World Health Assembly resolution WHA63.23: on WHO Global legally infant and young child nutrition binding World Health Assembly resolution WHA63.24: Non- Accelerated progress towards achievement of WHO Global legally Millennium Development Goal 4 to reduce child binding mortality: prevention and treatment of pneumonia World Health Assembly resolution WHA 63.25: Non- Improvement of health through on safe and WHO Global legally

environmentally sound waste management binding

World Health Assembly resolution WHA63.26: Non- Improvement of health through sound WHO Global legally management of obsolete pesticides and other binding obsolete chemicals World Health Assembly resolution WHA63.27: Non- Strengthening the capacity of governments to WHO Global legally constructively engage the private sector in binding providing essential health-care services World Health Assembly resolution WHA63.28: Non- Establishment of a consultative expert working WHO Global legally group on research and development: financing and binding coordination World Health Assembly resolution WHA62.10: Non- Pandemic influenza preparedness: sharing of details of the implementation of most of these WHO Global legally influenza viruses and access to vaccines and other resolutions are included as separate documents binding benefits (policies, frameworks, strategies, action plans) World Health Assembly resolution WHA62.12: Non- Primary health care, including health system WHO Global legally

strengthening binding World Health Assembly resolution WHA62.14: Non- Reducing health inequities through action on the WHO Global legally

social determinants of health binding World Health Assembly resolution WHA62.15: Non- Prevention and control of multidrug-resistant WHO Global legally tuberculosis and extensively drug-resistant binding tuberculosis World Health Assembly resolution WHA62.16: Non- Global strategy and plan of action on public health, WHO Global legally

innovation and intellectual property binding 88 World Health Assembly resolution WHA61.1: Non- Poliomyelitis: mechanism for management of WHO Global legally

potential risks to eradication binding World Health Assembly resolution WHA61.2: Non- Implementation of the International Health WHO Global legally

Regulations (2005) binding

Non- World Health Assembly resolution WHA61.4: WHO Global legally

Strategies to reduce the harmful use of alcohol binding World Health Assembly resolution WHA61.14: Non- Prevention and control of noncommunicable WHO Global legally

diseases: implementation of the global strategy binding Non- World Health Assembly resolution WHA61.15: WHO Global legally

Global immunization strategy binding Non- World Health Assembly resolution WHA61.17: WHO Global legally

Health of migrants binding World Health Assembly resolution WHA61.18: Non- Monitoring of the achievement of the health- WHO Global legally

related Millennium Development Goals binding details of the implementation of most of these Non- resolutions are included as separate documents World Health Assembly resolution WHA61.19: WHO Global legally (policies, frameworks, strategies, action plans) Climate change and health binding World Health Assembly resolution WHA61.20: Non- Infant and young child nutrition: biennial progress WHO Global legally

report binding World Health Assembly resolution WHA61.21: Non- Global strategy and plan of action on public health, WHO Global legally

innovation and intellectual property binding World Health Assembly resolution WHA60.1: Non- Smallpox eradication: destruction of variola virus WHO Global legally

stocks binding World Health Assembly resolution WHA60.14: Non- Poliomyelitis: mechanism for management of WHO Global legally

potential risks to eradication binding World Health Assembly resolution WHA60.15: Non- WHO Global

WHO’s role and responsibilities in health research legally 89 binding

Non- World Health Assembly resolution WHA60.16: WHO Global legally

Progress in the rational use of medicines binding World Health Assembly resolution WHA60.17: Oral Non- health: action plan for promotion and integrated WHO Global legally

disease prevention binding World Health Assembly resolution WHA60.18: Non- Malaria, including proposal for establishment of WHO Global legally

World Malaria Day binding World Health Assembly resolution WHA60.19: Non- Tuberculosis control: progress and long-term WHO Global legally

planning binding Non- World Health Assembly resolution WHA60.20: WHO Global legally

Better medicines for children binding World Health Assembly resolution WHA60.21: Non- Sustaining the elimination of iodine deficiency WHO Global legally details of the implementation of most of these disorders binding resolutions are included as separate documents Non- World Health Assembly resolution WHA60.22: (policies, frameworks, strategies, action plans) WHO Global legally

Health systems: emergency-care systems binding World Health Assembly resolution WHA60.23: Non- Prevention and control of noncommunicable WHO Global legally

diseases: implementation of the global strategy binding Non- World Health Assembly resolution WHA60.24: WHO Global legally

Health promotion in a globalized world binding World Health Assembly resolution WHA60.25: Non- Integrating gender analysis and actions into the WHO Global legally

work of WHO: draft strategy binding Non- World Health Assembly resolution WHA60.26: WHO Global legally

Workers’ health: global plan of action binding Non- World Health Assembly resolution WHA59.1: WHO Global legally

Eradication of poliomyelitis binding

90 World Health Assembly resolution WHA59.2: Non- Application of the International Health Regulations WHO Global legally

(2005) binding Non- World Health Assembly resolution WHA59.11: WHO Global legally

Nutrition and HIV/AIDS binding World Health Assembly resolution WHA59.12: Implementation by WHO of the recommendations Non- of the Global Task Team on Improving AIDS WHO Global legally Coordination among Multilateral Institutions and binding

International Donors World Health Assembly resolution WHA59.15: Non- Strategic Approach to International Chemicals WHO Global legally

Management binding World Health Assembly resolution WHA59.16: Non- Codex Alimentarius Commission: amendments to WHO Global legally

Statutes binding details of the implementation of most of these World Health Assembly resolution WHA59.17: Non- resolutions are included as separate documents Outcome of the first session of the Conference of WHO Global legally (policies, frameworks, strategies, action plans) the Parties to the WHO Framework Convention on binding

Tobacco Control World Health Assembly resolution WHA59.19: Non- Prevention and control of sexually transmitted WHO Global legally

infections: global strategy binding Non- World Health Assembly resolution WHA59.20: WHO Global legally

Sickle-cell anaemia binding Non- World Health Assembly resolution WHA59.21: WHO Global legally

Infant and young child nutrition 2006 binding Non- World Health Assembly resolution WHA59.22: WHO Global legally

Emergency preparedness and response binding Non- World Health Assembly resolution WHA59.23: WHO Global legally

Rapid scaling up of health workforce production binding

World Health Assembly resolution WHA59.25: Non- details of the implementation of most of these Prevention of avoidable blindness and visual WHO Global legally resolutions are included as separate documents

impairment binding (policies, frameworks, strategies, action plans)

91 Non- World Health Assembly resolution WHA59.26: WHO Global legally

International trade and health binding Non- World Health Assembly resolution WHA59.27: WHO Global legally

Strengthening nursing and midwifery binding World Health Assembly resolution WHA58.1: Non- Health action in relation to crises and disasters, WHO Global legally with particular emphasis on the earthquakes and binding tsunamis of 26 December 2004 Non- World Health Assembly resolution WHA58.2: WHO Global legally

Malaria control binding Non- World Health Assembly resolution WHA58.3: WHO Global legally

Revision of the International Health Regulations binding World Health Assembly resolution WHA58.5: Non- Strengthening pandemic-influenza preparedness WHO Global legally

and response binding World Health Assembly resolution WHA58.13: Non- Blood safety: proposal to establish World Blood WHO Global legally

Donor Day binding World Health Assembly resolution WHA58.14: Non- Sustainable financing for tuberculosis prevention WHO Global legally

and control binding Non- World Health Assembly resolution WHA58.15: WHO Global legally

Global immunization strategy binding Non- World Health Assembly resolution WHA58.16: WHO Global legally

Strengthening active and healthy ageing binding

World Health Assembly resolution WHA58.17: Non- International migration of health personnel: a WHO Global legally challenge for health systems in developing details of the implementation of most of these binding countries resolutions are included as separate documents

Non- (policies, frameworks, strategies, action plans) World Health Assembly resolution WHA58.22: WHO Global legally

Cancer prevention and control binding

92 World Health Assembly resolution WHA58.23: Non- Disability, including prevention, management and WHO Global legally

rehabilitation binding World Health Assembly resolution WHA58.24: Non- Sustaining the elimination of iodine deficiency WHO Global legally

disorders binding World Health Assembly resolution WHA58.26: Non- Public-health problems caused by harmful use of WHO Global legally

alcohol binding World Health Assembly resolution WHA58.27: Non- Improving the containment of antimicrobial WHO Global legally

resistance binding Non- World Health Assembly resolution WHA58.28: WHO Global legally eHealth binding Non- World Health Assembly resolution WHA58.29: WHO Global legally

Enhancement of laboratory biosafety binding World Health Assembly resolution WHA58.30: Accelerating achievement of the internationally Non- agreed health-related development goals, WHO Global legally including those contained in the Millennium binding

Declaration World Health Assembly resolution WHA58.31: Non- Working towards universal coverage of maternal, WHO Global legally

newborn and child health interventions binding Non- World Health Assembly resolution WHA58.32: WHO Global legally

Infant and young child nutrition binding

World Health Assembly resolution WHA58.33: Non- Sustainable health financing, universal coverage WHO Global legally

and social health insurance binding Non- World Health Assembly resolution WHA58.34: details of the implementation of most of these WHO Global legally resolutions are included as separate documents Ministerial Summit on Health Research binding (policies, frameworks, strategies, action plans) World Health Assembly resolution WHA57.1: Non- Surveillance and control of Mycobacterium WHO Global legally

ulcerans disease (Buruli ulcer) binding

93 Non- World Health Assembly resolution WHA57.2: WHO Global legally

Control of human African trypanosomiasis binding Non- World Health Assembly resolution WHA57.10: WHO Global legally

Road safety and health binding World Health Assembly resolution WHA57.11 Non- Family and health in the context of the tenth WHO Global legally

anniversary of the International Year of the Family binding World Health Assembly resolution WHA57.12: Non- Reproductive health: draft strategy to accelerate WHO Global legally progress towards the attainment of international binding development goals and targets World Health Assembly resolution WHA57.14: Non- Scaling up treatment and care within a coordinated WHO Global legally

and comprehensive response to HIV/AIDS binding Non- World Health Assembly resolution WHA57.16: WHO Global legally

Health promotion and healthy lifestyles binding Non- World Health Assembly resolution WHA57.17: WHO Global legally

Global strategy on diet, physical activity and health binding Non- World Health Assembly resolution WHA57.18: WHO Global legally

Human organ and tissue transplantation binding

World Health Assembly resolution WHA57.19: Non- International migration of health personnel: a WHO Global legally challenge for health systems in developing binding countries Non- World Health Assembly resolution WHA53.15: WHO Global legally details of the implementation of most of these

Food safety binding resolutions are included as separate documents

Non- (policies, frameworks, strategies, action plans) United Nations General Assembly resolution United Global legally

66/260: Improving global road safety Nations binding Non- United Nations General Assembly resolution United Global legally

66/231: Oceans and the law of the sea Nations binding

94 United Nations General Assembly resolution Non- United 66/229: Convention on the Rights of Persons with Global legally Nations

Disabilities and the Optional Protocol thereto binding United Nations General Assembly resolution Non- 66/227: International cooperation on humanitarian United Global legally assistance in the field of natural disasters, from Nations binding relief to development Non- United Nations General Assembly resolution United Global legally

66/224: People’s empowerment and development Nations binding Non- United Nations General Assembly resolution United Global legally

66/220: Agriculture development and food security Nations binding United Nations General Assembly resolution Non- United 66/215: Second United Nations Decade for the Global legally Nations

Eradication of Poverty (2008–2017) binding United Nations General Assembly resolution Non- United 66/183: International cooperation against the Global legally Nations world drug problem binding Non- United Nations General Assembly resolution United Global legally

66/172: Protection of migrants Nations binding

Non- United Nations General Assembly resolution United Global legally

66/158: The right to food Nations binding Non- United Nations General Assembly resolution United Global legally

66/148: International Covenants on Human Rights Nations binding Non- details of the implementation of most of these United Nations General Assembly resolution United Global legally resolutions are included as separate documents

66/141: Rights of the child Nations binding (policies, frameworks, strategies, action plans) Non- United Nations General Assembly resolution United Global legally

66/115: Global health and foreign policy Nations binding Non- United Nations General Assembly resolution United Global legally

65/95: Global health and foreign policy Nations binding

95 United Nations General Assembly resolution 65/238: Scope, modalities, format and organization Non- United of the high-level meeting of the General Assembly Global legally Nations on the prevention and control of non- binding

communicable diseases Non- United Nations General Assembly resolution United Global legally

64/255: Improving global road safety Nations binding United Nations General Assembly resolution 65/1: Non- United Keeping the promise: united to achieve the Global legally Nations

Millennium Development Goals binding United Nations Economic and Social Council Non- United resolution 2010/8: Tobacco use and maternal and Global legally Nations

child health binding United Nations General Assembly resolution Non- United 64/265: Prevention and control of non- Global legally Nations

communicable diseases binding Legally

The EU system EU Regional binding Commission Regulation (EC) No 540/95 of 10 March 1995 laying down the arrangements for reporting suspected unexpected adverse reactions which are not serious, whether arising in the Legally

EU Regional Community or in a third country, to medicinal binding products for human or veterinary use authorized in accordance with the provisions of Council Regulation (EEC) No 2309/93 http://ec.europa.eu/health/human- Regulation (EC) No 726/2004 of the European use/pharmacovigilance/developments/index_e

Parliament and of the Council of 31 March 2004 n.htm laying down Community procedures for the Legally EU Regional authorisation and supervision of medicinal binding

C. Regulation and control products for human and veterinary use and

establishing a European Medicines Agency Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 Legally amending, as regards pharmacovigilance, Directive EU Regional binding 2001/83/EC on the Community code relating to

medicinal products for human use

96 Regulation (EU) No 1235/2010 of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures Legally EU Regional for the authorisation and supervision of medicinal binding products for human and veterinary use and establishing a European Medicines Agency, and Regulation (EC) No 1394/2007 on advanced

therapy medicinal products Strategy to Better Protect Public Health by Non- Strengthening and Rationalising EU EU Regional legally n/a

Pharmacovigilance binding Implementing act on the requirements for the assessment of the regulatory framework applicable Non- http://www.ema.europa.eu/ema/index.jsp?cur to the manufacturing of active substances of EU Regional legally l=pages/medicines/landing/epar_search.jsp&m

medicinal products for human use – Concept paper binding id=WC0b01ac058001d125

submitted for public consultation EudraLex – Volume 4 Good manufacturing practice Legally EU Regional n/a

(GMP) Guidelines binding Commission Directive 91/412/EEC of 23 July 1991 laying down the principles and guidelines of good Legally EU Regional n/a manufacturing practice for veterinary medicinal binding

products Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of Legally good manufacturing practice in respect of EU Regional n/a binding medicinal products for human use and

investigational medicinal products for human use Note for guidance 2011/C 73/01 on minimising the Non- risk of transmitting animal spongiform EU Regional legally n/a encephalopathy agents via human and veterinary binding medicinal products EudraLex – Volume 3 Scientific guidelines for Legally EU Regional n/a medicinal products for human use binding Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Legally EU Regional n/a Community code relating to veterinary medicinal binding

products

97 Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Legally EU Regional n/a Community code relating to medicinal products for binding

human use Council Directive 90/385/EEC of 20 June 1990 on http://ec.europa.eu/health/medical- the approximation of the laws of the Member Legally EU Regional devices/files/revision_docs/entr_pe_dts_ia_md States relating to active implantable medical binding

_en.pdf

devices Council Directive 93/42/EEC of 14 June 1993 Legally EU Regional n/a

concerning medical devices binding Directive 98/79/EC of the European Parliament and Legally of the Council of 27 October 1998 on in vitro EU Regional n/a binding

diagnostic medical devices Non- http://www.who.int/medicines/publications/m

Medicines Policy WHO Global legally

onitor/en/index.html binding Non- http://www.who.int/gho/health_technologies/

Medical Devices: Managing the Mismatch WHO Global legally

medical_devices/en/ binding Non-

The International Pharmacopoeia (Ph.Int.) WHO Global legally n/a binding IMS Health Report to WHO Examines Effect of the Non- http://www.pharmaceuticalpolicy.nl/Publicatio Global Economic Crisis on Pharmaceutical WHO Global legally ns/Reports/Buysse_report%20impact%20reces

Consumption, Expenditure and Unit Prices binding sion_2010.pdf

n/a n/a n/a n/a n/a and licensing of D. Accreditation service providers

n/a n/a n/a n/a n/a quality of the the of quality individual and and individual social gradient health services E. Evaluation of of E. Evaluation community public public community delivered across the

98 EPHO 7: Assuring a sufficient and competent public health workforce Level: global, Evaluation notes (monitoring and assessment Lead Legal EPHO subdivision Title of instrument or tool with hyperlink regional, reports; activity reports; expected outputs; organization status national countries implementation; transparency) or local European mobility of medical and nursing Legally EU Regional n/a

workforce binding Non-

The OECD Human Resources for Health Care Study OECD Global legally n/a binding Non- Total number of qualified nurses and midwives per EU Regional legally n/a

100 000 inhabitants binding Non-

Practising physicians per 100 000 inhabitants EU Regional legally n/a binding Non- Physicians licensed to practise per 100 000 EU Regional legally n/a

inhabitants binding Non- Registered medical specialists - Absolute numbers EU Regional legally n/a

A. Human resources planning resources Human A. and rates per 100 000 of population, 2003 binding Non-

Practising dentists per 100 000 inhabitants EU Regional legally n/a binding Non-

Eurostat: Health statistics EU Regional legally n/a binding

Handbook on monitoring and evaluation of human Non- http://whqlibdoc.who.int/publications/2009/9 resources for health, with special applications for WHO Global legally

789241547703_eng.pdf

low- and middle-income countries binding

WHO Non- European Union Standards for Nursing and Regional http://www.euro.who.int/__data/assets/pdf_fi

B. Public health Regional legally

Midwifery: Information for Accession Countries Office for le/0005/102200/E92852.pdf

workforce standards workforce binding Europe

99 Non- WHO Global Code of Practice on the International http://www.who.int/hrh/migration/code/code WHO Global legally

Recruitment of Health Personnel _nri/en/index.html binding Non- http://www.euro.who.int/en/what-we- World Health Report 2006: Working together for WHO Global legally do/health-topics/Health-systems/health-

health

binding workforce/policy Directive 2005/36/EC of the European Parliament http://ec.europa.eu/internal_market/qualificati Legally and of the Council of 7 September 2005 on the EU Regional ons/policy_developments/legislation_en.htm#i binding

recognition of professional qualifications mplementation Council Directive 93/16/EEC of 5 April 1993 to http://eur- facilitate the free movement of doctors and the Legally EU Regional lex.europa.eu/LexUriServ/LexUriServ.do?uri=CE mutual recognition of their diplomas, certificates binding LEX:31993L0016:EN:HTML

and other evidence of formal qualifications

n/a n/a n/a n/a and and n/a C. education education C. accreditation

ing of n/a n/a n/a n/a n/a with impact other actors actors other D. Train

100 EPHO 8: Assuring sustainable organizational structures and financing Level: global, Evaluation notes (monitoring and assessment Lead Legal EPHO subdivision Title of instrument or tool with hyperlink regional, reports; activity reports; expected outputs; organization status national or countries implementation; transparency) local

WHO http://www.euro.who.int/__data/assets/pdf_fi Preliminary review of institutional models for Non- Regional le/0003/172731/Preliminary-review-of- delivering essential public health operations in Regional legally Office for institutional-models-for-delivering-essential- Europe binding A. Ensure A. Europe public-health-operations-in-Europe.pdf appropriate appropriate structures to structures deliver EPHOs organizational organizational

WHO Non- http://www.euro.who.int/en/who-we- European Observatory on Health Systems and Regional

B. Regional legally are/partners/observatory/health-systems-in- nal n of Policies Office for

binding transition-hit-series/about-the-hits-series structures

organizatio Europe Coordinatio WHO Non- Essential Public Health Operations (EPHO) and Regional http://www.euro.who.int/__data/assets/pdf_fi

Regional legally

Services in Europe (Annex 1) Office for le/0005/171770/RC62wd12rev1-Eng.pdf binding

Europe C. WHO http://www.euro.who.int/__data/assets/pdf_fi Non- assessment

Performance Review of public health capacities and services in Regional le/0010/172729/Review-of-public-health- Regional legally the European Region Office for capacities-and-services-in-the-European- binding

Europe Region.pdf

Legally http://ec.europa.eu/health/health_structural_f

The EU cohesion policy and health EU Regional

binding unds/policy/index_en.htm D. Investment in public health Non- Evaluating the costs and benefits of national

WHO Global legally n/a

surveillance and response systems binding Non- http://epp.eurostat.ec.europa.eu/portal/page/ services

Health systems expenditure EU Regional legally portal/health/public_health/data_public_healt E. Financing public health health public

binding h/database

101 EPHO 9: Advocacy, communication and social mobilization for health

Level: global, Evaluation notes (monitoring and assessment reports; Lead regional, Legal Title of instrument or tool with hyperlink activity reports; expected outputs; countries organization national or status implementation; transparency) local

Health communication for prevention and control of Non-legally ECDC Regional n/a communicable diseases binding

Non-legally

Health Communication ECDC Regional n/a binding Non-legally

Communicable disease prevention among Roma ECDC Regional n/a binding Non-legally

WHO Outbreak communication guidelines WHO Global n/a binding Non-legally

Communication toolkit on tick-borne diseases EU Regional n/a binding

102 EPHO 10: Advancing public health research to inform policy and practice Level: global, Evaluation notes (monitoring and assessment reports; Lead Legal Title of instrument or tool with hyperlink regional, activity reports; expected outputs; countries organization status national or implementation; transparency) local World Health Assembly resolution WHA62/16: Public health, Non-

innovation and intellectual property: global strategy and plan WHO Global legally http://apps.who.int/gb/CEWG/pdf/A62_R16-en.pdf

of action binding

World Non- Declaration of Helsinki – Ethical Principles for Medical

Medical Global legally http://www.who.int/bulletin/archives/79(4)373.pdf

Research Involving Human Subjects Association binding

103