designed by JP Advertising Ltd www.msa.org.mt Email: [email protected] Fax: 21242406 Tel: 21242420 Valletta, VLT10 Second Floor, Merchants Street, Evans Buildings, Malta Standards Authority ANNUAL REPORT2005-06 Malta Standards Authority ANNUAL REPORT 2005-06

Mission Statement

Our mission is to effectively co-ordinate standardization and related activities to meet the needs of the Maltese community in accordance with European and internationally recognized standards and practices, that enhance economic efficiency and international competitiveness, and fulfil the community’s demand for consumer protection and for a safe and sustainable environment.

02 Message by the Minister for Competitiveness and Communications

03 Message from the Chairman 06 Council of the Malta Standards Authority Table of 07 Message from the Chief Executive Officer 09 Accreditation Directorate Contents 12 Consumer and Industrial Goods Directorate 15 Foodstuffs, Chemicals and Cosmetics Directorate

17 Metrology Directorate 19 Standardization Directorate 21 Financial Statements

Malta Standards Authority 01 www.msa.org.mt

Message by the Minister for Competitiveness and Communications

Hon. Censu Galea

Year after year, the Malta Standards Authority increases its All of the above correspond to one of the Government’s key significance within the Ministry for Competitiveness and strategic documents, the National Reform Programme (NRP), Communications. International standards have been instrumental through which the country’s socio-economic development in the development of telecommunication networks, creating challenges, as well as Malta’s national competitiveness in terms more opportunities for small businesses. This is obviously of the relaunched Lisbon Strategy are addressed. The NRP reflected at the national level where the importance of standards aims to further promote enterprise and industry; tourism; and and their recognition is constantly increasing. the nation’s infrastructure, especially ports. This naturally cannot be achieved without the guidelines and safeguards of standards. The Malta Standards Authority is responsible for quality infrastructure in Malta. Over the past year, this responsibility Common regulatory requirements for products across Europe continued to be executed through regulatory and voluntary mean that goods can be traded freely. The Ministry for activities in the areas of technical regulation, standardisation, Competitiveness and Communications is responsible for this accreditation and metrology. All these contribute to the single sector and is technically supported by the MSA in its continuous aim, that of having producers, distributors, and service providers efforts to negotiate technical regulations at European level and delivering high quality services. implement them into Maltese law within the Better Regulation framework. In fact, following the establishment of the Better After all, in today's ever growing global manufacturing and trading Regulation Unit, Government announced the implementation of environment, consumers themselves rightfully expect to benefit a simplification action plan targeting both citizens and businesses. from access to a wider choice of goods and services, together The plan specifically identifies processes and forms which will with better quality. Yet, the services and products which we be simplified, further eGovernment services and ICT purchase should not only be consistent in quality, durability and improvements, consolidation of entities and setting up of one- ease of use, but also safe and ecologically friendly. In relation stop-shops and obsolete legislation which needs to be revoked. to this, it is of utmost importance that the MSA, as it has done in the past, persists in its endeavours to maintain and improve All of the above are initiatives for the accomplishment of these standards. With the aim to facilitate and help businesses sustainable development within a competitive market, with the in Malta, the MSA collaborates with the International Standards help of the Malta Standards Authority, we can achieve these Organisation (ISO), the International Electrotechnical Commission goals. (IEC), and the International Telecommunication Union (ITU), all of which develop voluntary international standards that facilitate trade, spread knowledge and share technological advances. ANNUAL REPORT 2005-06

Message from the Chairman

The role of the Malta Standardization Authority as it was known at that time, and unfortunately occasionally still referred to after six years was to prepare mandatory standards and to bring under one roof all government laboratories. Prior to my arrival, a decision was taken to establish the National Laboratory as a separate entity from MSA. This in my opinion was a wrong decision and at one of the first Council meetings which I chaired the members turned down my proposal to re-open the issue of the National Laboratory. There were no conflicting Ing. Francis E. Farrugia issues which prevented the co-existence of the National Laboratory. With the enactment of the Malta Standards Authority Act in July 2000, a new umbrella structure was established bringing together the technical regulatory functions, conformity assessment and standardization activities under one roof. This new Act, laid down the foundation for a new quality and measurement structure for Malta. The pre-accession funds made available to the Time for Authority during 2001 to 2004 were instrumental in capacity building both for purchasing metrological re-structuring equipment as well as for training the enthusiastic young the authority recruits who joined the Authority. All the targets established in the pre-accession project were met with time to spare. The first three years were crucial as the Authority was responsible not only to transpose Chapter 1 of the Acquis My recent re-appointment for another three- - The Free Movement of Goods, but to ensure that the year term is the third successive one. necessary infrastructure will be in place by accession When first appointed in 2000, the quality and participating in the various meetings with the Commission during the screening phase as part of the and measurement infrastructure in Malta Maltese delegation. The following were the main was inexistent. achievements during the period 2000 - 2002:

2000 - Malta Standards Authority Act 2000 - Membership of ETSI (European Telecommunication Standards Institute) 2001 - Five Directorates within MSA established 2001 - Full members of the European Standards Body, CENELEC and CEN (second amongst new Candidate EU Member States) and of ISO (International Standards Organization) 2002 - First national standards published.

Malta Standards Authority 02-03 www.msa.org.mt

During this period, all the New Approach Directives were 2003 - Full members of EA (European co-operation for transposed under the Product Safety Acts as well as a Accreditation) number of directives dealing with food safety under the 2003 - MSA established as the Competent Body for Food Safety Act. Malta for EMAS (Environmental Management and Audit Scheme) and EU Eco-label While for the period 2001 - 2003, the emphasis was to 2003 - Quality Management System Certification ensure that Malta would be ready to take on the Acquis Services setup obligations on Accession in May 2004, the period 2004 2004 - MSA certified to MSA EN ISO 9001 by BSI - 2006 was characterised by participation at the various 2004 - Full members of EUROMET and WELMEC (both Commission and Council Working Parties meetings European Metrology Organisations) (practically once a week), notably the Motor Vehicle, 2004 - National Measurement System and Calibration REACH and pyrotechnics directives which all would have laboratories fully operational left a negative effect on Malta’s industry and tradition if 2004 - First EMAS site registered (first amongst new our participation was missing. Also, conformity assessment Member States) - ST Microelectronics activities in the areas of certification and accreditation 2004 - First Accreditation certificate issued - started to take up. Our industrial metrology service Institute of Water Technology, Water Service (calibration) was instrumental for the pharmaceutical Corporation companies which were setting up shop in Malta. In 2006, 2004 - First ISO 9001 Certificate issued - Internal Audit European and Government funds were made available Unit, Maltacom to consolidate further the quality and measurement 2004 - Awarded ‘Premio - Qualita Ambientale Europea’ infrastructure for the purchasing of further metrological by the Italian body APAT equipment and to achieve European and international 2005 - First European standards translated into Maltese recognition in the areas of conformity assessment. language The major problem that we were constantly and are still 2006 - Hilton Malta awarded the EU Eco-label. facing is that of the shortage of human resources. The major achievements during this period were: ANNUAL REPORT 2005-06

During 2006, we have also left our mark in the international manageability of the Authority considering the dual arena. The role that we played to safeguard Maltese responsibilities, one as a regulatory body acting on behalf industries interest during the various Commission Working of the Ministry and the other as a standardization body Group meetings, especially in the REACH and operating in the voluntary sector. In the next three years, Pyrotechnics directives were commended by all the major thrust will be in the re-structuring of the Authority concerned. For the first time, we were commissioned by both in its operative and administrative setups by preparing CEN as contractors to the European Commission’s MEDA a new legislation. The first decision has already been project to run two workshops one in Malta and another taken. As from November this year, Accreditation activities one in Casablanca on the ACAA (Agreements for will be transferred from the Authority to the Ministry, it Conformity Assessment and Acceptance of Industrial will now be known as NAB-Malta. This move was Products). This Agreement was originally devised to envisaged way back in 2002 when we commissioned a Malta prior to our accession to the EU and it is now being feasibility study by a European expert on the matter. applied to Mediterranean countries in conjunction with Certification and calibration activities are not compatible the EuroMed Free Trade Agreement. with accreditation if these are under one roof. Early in 2007, the certification service will undergo accreditation At the last General Assembly of ISO in Ottawa, Canada assessment and the calibration laboratory will undergo we were nominated for the General Council and obtained for the first time a Peer Evaluation Exercise and later in the highest number of votes from among the contesting the year accreditation. The year 2007 is going to be a countries in our category. We now have a seat on the decisive year for the Authority. In conclusion, I would like ISO General Council for the period 2007 - 2008. The to thank Mr. Joseph Spiteri the outgoing CEO of the Council is the governing body of ISO. Authority since its inception for the sterling work done during his tenure. During these six years, we had to manage within the constraints of the MSA Act of 2000. The present setup within the Authority is not fully compatible with international requirements and there is also the question of the Malta Standards Authority 04-05 www.msa.org.mt

Council of the Malta Standards Authority

1 2345

6 78910

11 12 13 14 15

Record of Attendance at Council Meetings

Name 2005 2006

7th Council Meeting: 8th Council Meeting: 1st Council Meeting: 2nd Council Meeting: 31st October 20th December 25th July 21st August

01. Ing. Francis E. Farrugia P P P P 02. Mr. Godwin Warr P E P P 03. Mr. John Mifsud E P E P 04. Mr. Anthony Mifsud P E E P 05. Mr. Marcel Pizzuto1 EEEE 06. Profs. Ing. Paul Micallef 2 --PP 07. Mr. Piu J. Camilleri3 --PP 08. Dr. Godwin Cassar P E P P 1 Mr. Marcel Pizzuto was 09. Dr. Malcolm Micallef E P E P appointed as Permanent 10. Perit Nicholas Samut-Tagliaferro P P P P Secretary in the Ministry for 11. Mrs. Marianne Sant Fournier P P E P Competitiveness and 12. Dr. Louis Zammit Mangion P P P P Communications. 13. Dr. Brian Warrington - - P P 14. Mr. Andrew W. J. Mamo E P E P 2 Profs. Ing. Paul Micallef was 15. Mr. Godwin C Micallef P P P P nominated by the Chamber of 16. Dr. Ing. Jonathan C. Borg P P - - Engineers instead of Dr. Ing 17. Mr. Joseph Tabone E P - - Jonathan C. Borg.

3 Mr. Piu J. Camilleri was NB: E – Excused P – Present nominated by the GRTU 2006 – 2008 MSA Council was appointed in July 2006 instead of Mr. Joseph Tabone. ANNUAL REPORT 2005-06

Message from the Chief Executive Officer Mr. Joseph Spiteri

The year under review saw the Malta Standards Authority consolidating further its position by a number of initiatives. First of all, the Malta Standards Authority continued to identify relevant projects financed by the EU under the Transition Facility programme. During the year under review, the Pre-Accession Environment project was successfully terminated and the Pre-Accession projects were commenced.

Pre-Accession 2003 Transition Facility 2004

SPECIALISED INDUSTRIAL PROCESSES AND ADDITIONAL SUPPORT IN SPECIFIC TECHNICAL ENVIRONMENTAL AUDITS PROJECT AREAS FOR THE CONTINUED EFFECTIVE This project started in May 2005 and came to an end in IMPLEMENTATION AND OPERATION OF THE August 2006. The objectives of this project were to MARKET SURVEILLANCE SYSTEM IN MALTA provide technical assistance and training on PROJECT Environmental Management Systems, EMS), the Under this project the Authority benefited from training European Union’s Eco-labelling Scheme to participating and procurement of equipment for the National Metrology entities and MSA. A feasibility study was carried out to Services of MSA. investigate how Government can create initiatives to support organisations that adopt EMS. Two service contracts were awarded for Training in Humidity Measurement and Toxicology and Humidity All the set objectives were attained and the project was measurement training. This training will enhance the regularly monitored during its implementation. The number MSA staff capabilities to support the Market Surveillance of participants in EMS Internal Auditors course were System in Malta. Furthermore, under this same project encouraging. the MSA is to procure equipment valued at EUR 439,000 which is being co-financed between the EU Commission During a half-day seminar for the tourism sector, the and the Government of Malta. In order to house this Hilton Malta Hotel was awarded the Eco-label Award equipment, the Government of Malta is refurbishing a and the experience of this hotel was shared with the new extension to the existing metrology laboratory. representatives of the other hotels attending this seminar. Further Institutional Building, Consolidation and Strengthening of the Malta Standards Authority project.

Malta Standards Authority 06-07 www.msa.org.mt

This service tender was awarded to the British Standard and within the Consumer and Industrial Goods Directorate Institute in June 2006 after an open call for tender. to carry out its responsibilities under Directive 70/156/EEC. The project was implemented immediately given that REACH would introduce a number of new obligations this contract would provide the needed expertise to MSA on Member States, not contemplated by current chemicals in the following sectors: legislation on new and existing substances (Directives • Assistance to the Consumer Industrial Goods 76/769/EEC, 67/548/EEC and Regulation 793/93). Directorate and the NAB-MSA to develop the The Foodstuffs, Chemicals and Cosmetics Directorate necessary competence to be able to administer of the Malta Standards Authority will be the future the system for Notified Bodies and Conformity Competent Authority for REACH. It is currently the Assessment Bodies in Malta; Competent Authority for new and existing substances, • Assist the Accreditation Directorate (NAB-MSA) to as well as for classification and labelling. Implementation fulfil the European Accreditation Multilateral of the new policy will cause fundamental changes in Agreements (EA MLA) requirements; legislation concerning the manufacture and importation • The development and implementation of the of chemicals, placing on the market and use of chemical E-Signatures Accreditation Scheme; substances and preparations, and substances in articles. • The provision of expert advice to MSA as the Competent Authority in Malta to implement the Eco COMPETENT AUTHORITY FOR (MOTOR VEHICLE) Management and Audit Scheme (EMAS) in Malta; TYPE APPROVAL • Development of the Good Laboratory Practice As the Maltese Type Approval Authority for Motor Vehicles, Scheme for Chemicals; the Consumer and Industrial Goods Directorate (CIGD) • MSA will be seeking accreditation of its certification of the Malta Standards Authority is both legally and unit; administratively responsible under both the EU and UN- • Expert advice to MSA in developing an appropriate ECE type approval schemes. In order to be able to meet infrastructure in establishing national Eco-Label the above requirements, CIGD needs to build the schemes; necessary technical and administrative infrastructure to • MSA personnel will be trained in organic farming enable it to fully perform its (Motor Vehicle) Type Approval certification procedures; functions for the full implementation of this part of the • MSA is the Malta Notification Point regarding technical acquis. Type approval is the confirmation that production standards, regulations and information society. samples of a design will meet specified performance standards. The specification of the product is recorded The project started by the preparation of an action plan and only that specification is approved. for the EA MLA process. A new legal draft has been prepared to change the set up of the National Within the EU, harmonization of technical requirements Accreditation Body in line with EA MLA requirements on motor vehicles has so far been achieved for three and meetings with local authorities regarding electronic categories of vehicles namely, passenger cars, signatures and the preparation of a discussion paper on motorcycles and tractors. The EC Whole Vehicle Type- the scheme to be developed in Malta. MSA staff has Approval (WVTA) system has applied, on a mandatory also started attending to courses abroad falling under basis, to passenger cars since January 1998, to the above-mentioned activities. This project is to be motorcycles since June 1999 and to tractors as from finalised by end 2007. July 2005. As a result, these categories of vehicles must comply with all the relevant European type-approval Transition Facility 2006 directives in order to be placed on the market. After the termination of these twinning light projects, the Malta The Authority applied for a project under the 2006 Standards Authority will be in a position to fully meet its Transition Facility to be able to fully meet its obligations obligations arising from the acquis in relation to the new arising from the acquis in relation to the: EU chemicals policy, contained in the REACH legislative • New EU chemicals policy, contained in the REACH proposal, and (Motor Vehicle) Type Approval functions. legislative proposal, and • (Motor Vehicle) Type Approval functions Conclusion This project consolidated the Capacity Building of the Malta Standards Authority as the Competent Authority for My present contract as Chief Executive with the Malta REACH which is the new EU regulatory framework for Standards Authority will come to an end on 31st the Registration, Evaluation and Authorisation of Chemicals December 2006 which will coincide with my retirement (REACH) and as the MSA being a Maltese Type Approval date. The Authority was established in December 1996 Authority project. The project fiche proposing the light since the coming into force of the Malta Standardisation twinning projects was approved during year 2006 and the Act Cap. 147 and I was the first official of the Authority. implementation stage will start in 2007. The value of this The Authority has made great progress since that date project is EUR 175,500 which will be totally EU funded. and established itself as a recognised standardisation body in Malta. The personnel was increased over the COMPETENT AUTHORITY FOR REACH years and were trained abroad to attain the present The purpose of the project is to assist in the setting up knowledge that they possess. In the circumstances I of the necessary administrative and technical structures wish the Authority the best of luck to continue in its within the Foodstuffs, Chemicals and Cosmetics endeavour to obtain the necessary know-how for the Directorate to implement its responsibilities under REACH present and future benefit of the country. ANNUAL REPORT 2005-06

Ing. Claudio Boffa Accreditation Directorate ISO17011 defines accreditation as third party attestation related to a conformity assessment body conveying formal demonstration of its competence to carry out specific conformity assessment tasks. Key words from this definition are:

• “third party attestation” which means the process undertaken by the National Accreditation Body of the Malta Standards Authority Accreditation Body (NAB-MSA) to assess the competence of a CAB, based on Assess Competence particular standard(s) and/or other normative documents and for a defined scope of accreditation. Assessing the competence of a CAB involves assessing the competence of the entire operations Conformity Assessment Bodies of the CAB, including the competence of the personnel, the validity of the conformity assessment methodology and the validity Assess Conformity of the conformity assessment results.

• “conformity assessment body” which refers to a laboratory, inspection body, certification body, notified body or any other body offering conformity assessment services. Products (including services) Accreditation is all about PROOF OF COMPETENCE. In a number of areas it is a requirement to obtain accreditation before offering Supplier certain services; in others it is a de facto ‘licence’ to trade in that key purchasers expect it. Accreditation provides market differentiation and objective proof that an organisation complies Accreditation bodies assess the with best practice. It is the internationally-recognised system that competence of CABs. They can is used to develop and sustain high standards of performance. It facilitate trade by promoting global is a winning formula for eligibility to tender and for international acceptance of conformity assessment trade. results issued by accredited CABs. This is strengthened if they are peer- evaluated and are members of mutual 2006 - A Year of Developments and Changes recognition arrangements among the accreditation bodies. The year 2006 turned out to be yet another very busy year for the National Accreditation Body (NAB) which, apart from the day CABs assess conformity of products, to day running of the accreditation activities, was also involved services, and suppliers to in a number of other projects and activities. specifications and/or requirements. (A) APPLICATION TO SIGN THE EA MLA Purchasers acquire products In September the NAB submitted its application to sign the EA (including services) that conform to MLA in the testing area. This required an in-depth review of the specifications or buy from suppliers current operations of the NAB and a revision to some of the that conform to specific requirements. documents and regulations have been carried out in liaison with Regulators may set requirements for Mr. John Hussey who is giving technical support to the NAB staff products and suppliers. to achieve the MLA signatory status.

Malta Standards Authority 08-09 www.msa.org.mt

It is now up to the committee within EA which takes care Malta is also one of the few countries in which there is of organising the peer evaluations, to set a date for the no association of laboratories which could represent this visits to the NAB by an EA team to be carried out. The sector of the Maltese economy in various fora and Multilateral agreement (MLA) facilitates free movement committees. In fact a post within the Accreditation Advisory of products and services within Europe and the rest of Board for a representative of such an association has the World. The MLA eliminates the need for suppliers of been vacant since the inception of this Board. Such an goods or services to be certified in each country where association would also enhance the networking of Maltese they sell their products or services. In other words, any laboratories not only on a national scale but also on a product or service that have the accreditation body’s European and international scale. Networking on a local mark on the certificate or test report that are exported scene would help to synergise better the limited resources to another country will be accepted, and not subject to available whereas networking on an international scale additional tests or inspection. would help to increase the knowledge, expertise as well as the competitiveness of the Maltese laboratories. Such The MLA supports accreditation being a “passport” which an association could also become a member of Eurolab facilitates access to the EU and international markets which formulates and voices the opinion of European through co-operation with ILAC (International Laboratory laboratories regarding political and technical issues Accreditation Co-operation) and IAF (International having a direct impact on their activity, both on the Accreditation Forum). All EA members that are signatories European scene and worldwide; co-ordinates laboratory to the EA MLA are subject to regular and stringent peer work by interfacing with partner organisations having evaluations conducted by the other EA members. The activities of interest to the laboratory community, and purpose of these evaluations is to verify the signatories’ striving to avoid duplication of efforts and activities, continuing conformity with the internationally accepted providing adequate means for exchange of information criteria. These peer evaluations ensure consistent, and experience, such as the publication of our Position harmonized accreditation practices and also facilitate Papers, Technical Reports, Newsletters, Seminars, and the exchange of information and experiences between Working Groups etc. and also promotes cost-effective the signatories. testing, calibration and measurement services, for which the accuracy and quality assurance requirements should (B) NEW EU-MALTA CO-FUNDED TRANSITIONAL be adjusted to actual needs. FACILITY PROJECT In May of 2006, MSA signed a contract with the British The NAB also worked to try to develop a national Standards Institution. The main objective of this contract accreditation scheme for electronic signatures. It also is to consolidate and strengthen the main activities carried set up a technical committee to try to unlock this issue. out by the Authority. This project, which should be finalised However, due to the non-harmonization of this scheme by end December 2007, will provide technical assistance within Europe a number of difficulties were met. Through to the NAB in the following areas: the consultancy being provided through the BSI Transition • Peer evaluation by the EA which should lead the Facility project, the NAB will be finalising its view on this NAB to sign the EA MLA; matter by the preparation of a draft scheme. • Accreditation of EMAS verifiers; • Accreditation scheme for electronic signatures; The NAB continued to updated its Assessors Database. • Assessment of Notified Bodies and Conformity Due to the nature of the operations, the NAB relies on Assessment Bodies working in relation to local the expertise of contracted assessors. The NAB will also legislation; soon be issuing a call of expression of interest for those • Monitoring of GLP facilities. wishing to become technical assessors.

(C) ACCREDITATION ACTIVITY Due to the nature of accreditation, some changes to the The accreditation activity increased. The area of laboratory structure of NAB were also required. A new legal notice accreditation is developing slowly but steadily. The NAB establishing the provision of accreditation service in continued with the surveillance visits of the two accredited Malta was prepared and will soon be published. This laboratories namely the Institute of Water Technology new legal notice will establish the NAB as a Board under and Synergene Technologies Limited. The assessment the direct responsibility of the Ministry of Competitiveness of the former is done jointly with the United Kingdom of Communications and the Head of the NAB will now Accreditation Service (UKAS). Three new applications be reporting directly to the Permanent Secretary within from laboratories have been received and are being this Ministry. However, close liaison with the Malta processed. Two of these applicants are at quite an Standard Authority in the issues related to standardization, advanced stage. The third applicant has undergone the notified bodies and metrology which together with preliminary visit and will soon be undergoing its accreditation are the columns of the quality infrastructure assessment visit. An application for an extension to of any economy will continue to be important aspects of scope was also received. Some of these laboratories the setup. As the accreditation body in Malta responsible are offering a number of tests using technologies and for EMAS Verifiers, the NAB has also been in contact techniques which are quite advanced. It must be noted with the Verifiers currently responsible for the only EMAS here that when compared to countries with an economy site in Malta, namely ST Microelectronics. The NAB is with a scale similar to that of Malta the number of preparing to carry out the first supervision of these laboratories accredited in Malta is still very low. verifiers. ANNUAL REPORT 2005-06

(D) RELATIONS WITH EA Board Member Organisation Ing. Joseph Bartolo European co-operation for National Metrology Services - Accreditation Malta Standards Authority During 2006 the NAB had the opportunity to attend the Ing. Claudio Boffa EA General Assemblies, the EA Multilateral Agreement National Accreditation Body - Committee meetings and meetings of the EA Laboratory Malta Standards Authority Committee. Through this participation the NAB continued Mr. Nicholas Crockford to foster its relationship with the members of EA which Malta Tourism Authority are vital for its operations. In fact the NAB has very good Ing. Francis E. Farrugia relationships with UKAS, INAB, SINAL, SINCERT, SIT Malta Standards Authority and SWEDAC. Through its participation the NAB could Ms. Moira Pace also defend the interest of the Maltese conformity Ministry for Rural Affairs & the Environment assessment bodies. Ing. Stephen Rizzo Federation of Industry For the first time, Malta hosted a meeting of EA. This Ms. Rose Schembri was the Inspection and Certification Committee. Ministry for Health, Elderly & Community Care Mr. Joseph A. Spiteri In May the NAB welcomed Mr. Graham Talbot, the Vice- Chamber of Commerce and Enterprise Chairman of EA. Mr. Talbot was in Malta to collect Mr. Noel Toledo feedback about the operations of EA and possible Ministry for Competitiveness & Communications improvements that can be made to the EA infrastructure. Mr. Stefan Xuereb During his visit, Mr. Talbot also had the opportunity to Consumers Association meet the Chairman of the Malta Standards Authority, The Board members gave valuable input to the NAB. Ing. F. E. Farrugia, the Permanent Secretary within the Ministry of Competitiveness and Communications, Mr. Marcel Pizzuto and the Hon. Minister for Competitiveness and Communications, Arch. Censu Galea.

(E) TRAINING OF STAFF Training of staff continued in earnest. The NAB staff attended a course on Environmental Management System internal auditing and a course for EMAS Verifiers. The NAB Staff also attended a Lead Auditors course run by BSI to update their knowledge and keep abreast of recent Whenever resources permitted, the NAB also participated challenges in auditing Management Systems in a process in the standardization process and gave its input to the approach style. Through the EU funded project, the NAB development of National Standards. staff also attended a GLP Inspectors Training Course organised by OECD. The NAB also assisted the MSA, who is the Eco-label Competent Authority in Malta, to carry out the first (F) CO-ORDINATION OF THE ENVIRONMENT assessment of a tourist accommodation service which PROJECT resulted in the first Eco-label award being awarded to a After the MSA managed to get hold of pre-accession Maltese-run hotel. funding related to environmental management systems, a tender was prepared and eventually awarded to local The NAB also provided its services to MSA to help it to contractors, ADI Ltd. who worked together with Tuning maintain its certification to ISO9001 by managing its Fork Ltd. as well as with a number of other renowned quality management system. It co-ordinated and executed institutions including IEMA, UKAS and DEFRA. This the internal audits within the Authority and also maintained project, which was given the name M-EMS, gave the the necessary databases to ensure that the system is possibility to a number of organisations both from the controlled and maintained. public and private sector to attend a number of EMS implementation workshops, an EMS internal auditors A review of the website is currently underway to ensure course, an EMAS Verifiers Course and seminars on the that it is providing the necessary information required Eco-label. by the clients of the NAB. A user-friendly approach has been adopted and it is the intention of the NAB to (G) OTHER ACTIVITIES continually improve its electronic services. The NAB The NAB also convened the Accreditation Advisory website will now be hosted at www.nabmalta.org.mt Board 3 times during period covered by this report. The current composition of the Accreditation Advisory Board is:

Malta Standards Authority 10-11 www.msa.org.mt

Consumer and Industrial Goods Directorate

Ing. Anthony Camilleri

The period encompassing October 2005 - September national “small series” derogations) to passenger cars 2006 saw the Consumer and Industrial Goods Directorate (category M1). The re-cast Directive will extend ECWVTA (CIGD) strengthening its existing cooperation with the to all other categories: goods vehicles (Category N); Ministry for Competitiveness and Communications buses/coaches (Category M2, M3; and trailers (Category (MCMP), with other Government entities, constituted O). Measures are also being proposed to control the bodies, economic operators and the general public, in sale of after-market parts and accessories where they order to implement better regulation. pose a significant risk to the functioning of a vehicle. On 16 February 2004 the European Parliament adopted The accelerating pace of change in the economy its opinion at first reading, with a number of amendments demands continuous adaptation of regulation to meet whilst on 4 November 2004 the Commission presented new needs and circumstances. amendments to its original Proposal. These incorporated one amendment adopted by the Parliament and partial The Directorate’s experience in product regulation and acceptance of a further 9 amendments. The remaining its management, and its track record in developing 14 amendments adopted by the Parliament were rejected. alternative forms of regulation (and alternatives to These discussions in Council were concluded under the regulation) have resulted in it taking a leading role in UK Presidency on 23 November with a broad consensus discussions taking place both locally and at EU level on on the main legislative text and on consequential new proposed regulations, always keeping in mind the amendments to the Annexes, with only two main issues strict observance of the EU Commission's position on remaining outstanding and a further six lesser issues to the precautionary principle, and in particular proper risk be resolved. On 7 December 2005, the Permanent assessments as a basis for risk management measures Representative Committee reached a political agreement as well as the full consultation of relevant stakeholders on the draft Directive that was forwarded to Council as on the proposals and the assessments carried out. an "A" point.

This concise report covers the Directorate’s activities COMPETITIVENESS AND GROWTH ("PRE- and achievements over the past year and highlights PACKAGING") WORKING PARTY, where the “Amended some of the work planned for the forthcoming year. Proposal for a Directive of the European Parliament and of the Council laying down rules on nominal quantities for pre-packed products, repealing Council Directives Representation in Council 75/106/EEC and 80/232/EEC, and amending Council Working Parties Directive 76/211/EEC” (COM(2004)708 as amended by The CIGD, acting in its technical advisory capacity to COM(2006)17) was examined in 2005. After this, the the MCMP, covered four Council Working Parties during Commission's amended Proposal was discussed twice this period, namely: during 2006, the first time during the Austrian Presidency last spring at an attaché-meeting and then during the TECHNICAL HARMONISATION ("MOTOR VEHICLES") Finnish Presidency, on 7 September 2006 in the Working WORKING PARTY, where the recast version of the Party on Competitiveness and Growth. The proposal “Proposal for a Directive of the European Parliament aims to simplify the current EC legislation prescribing and of the Council on the approval of motor vehicles and nominal quantities. It will deregulate current EC and their trailers, and of systems, components and separate national legislation in this area. As an exception, fixed technical units intended for such vehicles” (COM(2003) mandatory nominal quantities will remain only in the 418) has been extensively discussed at 29 meetings in wine and spirits sectors, reflecting only those quantities a little over two years. Infact, on 18 July 2003 the most sold to consumers whereas as part of the Commission presented its Proposal whose main purpose compromise text, it is expected that the Directive would is to further develop the internal market for all road-going allow for a three to five year phase-out of national nominal vehicles by extending the mandatory entry-into-service quantities (where these already exist) for white sugar, requirements of EC Whole Vehicle Type Approval milk, pasta, butter and coffee. (ECWVTA). Currently, these only apply (with limited ANNUAL REPORT 2005-06

TRADITIONAL PYROTECHNIC ARTICLES

PHARMACEUTICALS AND MEDICAL DEVICES • The decision-making process, by allowing binding WORKING PARTY, where the “Proposal for a Directive decisions in case of conflicting national of the European Parliament and of the Council amending interpretations on whether or not a product is a Council Directives 90/385/EEC and 93/42/EEC and medical device. Directive 98/8/EC of the European Parliament and the Council as regards the review of the medical device TECHNICAL HARMONISATION ("PYROTECHNIC directives” (COM(2005)681) was examined at its 2006 ARTICLES") WORKING PARTY, where the “Proposal meetings on 23 and 24 January, on 6 and 7 February, for a Directive of the European Parliament and of the on 20 February, on 6 and 7 March, on 20 and 21 March, Council on the placing on the market of pyrotechnic on 20 and 21 April, on 2 and 3 May, on 7 and 20 June, articles” was debated on 4 and 10 July 2006 and on 7 on 10 July and on 4 September. During these meetings and 21 September 2006. The proposal intends to a first reading of the text has been completed. Malta, harmonize the EU approach on standards for pyrotechnic together with several other delegations, has submitted articles, thus ensuring that sub-standard pyrotechnic written comments to the text, which have been circulated articles are not placed on the EU market and should as Working Documents. The Commission representatives result in a significant reduction in the number of accidents have provided explanatory documents, which have also caused through the malfunction of a firework. It extends been circulated to delegations. Medical devices are the CE marking of pyrotechnic articles with the result currently regulated under three main Directives covering that only CE marked pyrotechnic articles can be placed respectively active implantable medical devices (AIMD), on the market. medical devices (MDD) and in vitro diagnostic medical devices (IVDD). In vitro refers to tests performed on A harmonized EU approach to the provision of information samples - for example blood, tissues or urine - outside on the safe handling and use of pyrotechnic articles the living body and in an artificial environment. Due to might also be helpful in reducing the number of accidents technical differences between the three directives, the resulting from misuse. Furthermore, a harmonized Commission has decided against a merger of the approach to the categorisation, use of standards, and directives. At the moment, better regulation will therefore approval system in relation to pyrotechnic articles should be achieved through regulatory clarifications to ensure lead to significant benefits in terms of product safety consistency of interpretation and implementation. Medical coupled with a single market for manufacturers and devices comprise any instrument, appliance, software, importers. At the same time, taking into account the etc. used for the purpose of disease prevention (e.g. variety of different national regulations on the marketing vaccine-delivery devices), screening (e.g. mammography and use of fireworks, the proposal leaves the possibility for breast cancer), diagnosis (e.g. use ultrasound system) for Member States to maintain their own regulations as or treatment or alleviation of disease. Recent public far as the minimum age and the marketing and use of concern about breast implants, dialysers etc. shows that certain categories of fireworks are concerned. the medical devices sector represents a high profile activity and that the public expects enhanced safety Malta expressed its support in favour of the general standards. The Commission draft proposal scope of the proposal, as it is in favour of creating a considers relaxing confidentiality to allow certain comprehensive and coherent legislative framework at information on all devices to be publicly available, thus Community level and introducing minimum safety improving transparency. It also proposes changes to the requirements. However, following long technical classification of medical devices. Further, the proposed consultations with all local stake-holders, Malta requested amendments are intended, among others, to improve: exemptions for traditional hand-made fireworks used • Clinical evaluation, through clarification of the specifically during traditional Maltese religious festivals requirements, and which are not sold to consumers, on the premise • Post market surveillance, to increase transparency that one can never speak of 'harmonizing' traditions and for the general public, works of art. All indications to date are positive and point • Consistency between the medical devices and the in this direction, culminating long months of work, active implantable medical devices directives, consultations and meetings to achieve these exemptions.

Malta Standards Authority 12-13 www.msa.org.mt

Staff Development implementation is envisaged to start in early 2007. The value of this component of the CIGD officials benefited from several training project is EUR 51,500 which will be totally opportunities, both in-house as well as funded by the EU. through direct experience with other EU competent authorities, namely: Conclusion Phase I of the 2004 Transition Facility: “Additional Support in Specific Technical The period under review saw the Areas for the Continued Effective “breakthrough” in the general thinking about Mr. Joel Hasse Ferreira, MEP, Implementation and Operation of the Market the co-operation between this regulatory Socialist Group in Europe Surveillance System in Malta” project where Directorate, Ministries, Departments, other (PSE), is seen (second from CIGD staff continued to receive training in Authorities, MEPs, economic operators, etc… right) during his visit to Malta the fields of Recreational Crafts, Lifts and Clearly, the improved communication and last June, when a meeting Medical Devices. This training consisted tremendous joint-effort that has been with the CIGD Director was primarily of CIGD officials spending a week maintained amongst CIGD and all these key organised specifically to with our counterpart competent Authority in stake-holders has rendered the strategic discuss the EP proposed another Member State (Austria for approach to influencing the European policy amendments. Recreational Crafts/Lifts and the Netherlands process a genuine success. Talking about for Medical Devices) in order to get first hand the CIGD, the question is not any more about experience on how these Directives are being how to forward or process information implemented in practice. It is envisaged that between all national stake-holders and the during the coming months, phases II and III CIGD, but rather how to operate within a very of this project shall cover other industrial effective, fast and “proactive” network of sectors including Electrical Equipment, technical people, how to explore all Personal Protective Equipment and possibilities of using existing communication Construction Products. channels. It is also a question of using all the Euromed Quality Programme, where CIGD good ideas and experiences generated within officials attended several seminars and such a small department where every official workshops including: is given his chance to develop further his/her CIGD staff, together with • Workshop on the implementation of the skills and feel proud of his/her valuable input. other officials coming from Construction Products Directive: the In this challenging time our strategy can only the MSA, the Market UK experience, held in London on 8th be to exploit all possible synergies between Surveillance Directorate and and 9th November, 2005. all key stake-holders, requiring all of us to Health Division seen here • European Construction Network (ECN) operate a real partnership between together with BSI tutors. meeting held in London on 10th and “regulators” and “operators” through sharing 11th November, 2005. experience and best practices, and by working • Evaluation Conference on the together in the regulatory arena. Construction Products Directive held in Brussels on 16th and 17th November, For the immediate future, the CIGD needs 2005. to move ahead - gaining more speed by the • ‘Training Programme for Personnel of very positive feedbacks from the results Testing Laboratories Operating in obtained so far - by setting SMART goals to relation with the Electromagnetic be achieved (Specific, Measurable, Compatibility and Low Voltage Directive’ Achievable, Realistic, Time-based). In the that took place on 2nd and 3rd context of “better regulation” and the “Lisbon February, 2006 in Brussels. Agenda”, the Directorate’s vision is to have • ‘Training Programme for Personnel of our steps measured and evaluated. We would Testing Laboratories Operating in like to see all key stake-holders actively relation with the Pressure Equipment participating in those consultative forums Directive’ that took place on 15th and where broad discussions and opinions often 16th February, 2006 in Brussels. subject to challenge should take place. A true • Lead Auditors Course (ISO 9001) held partnership must work both ways. The CIGD at the MSA from 12th - 16th June 2006. must continue to provide prompt and professional support for the national key Transition Facility 2006: Competent Authority stake-holders on National/European for (Motor Vehicle) Type Approval regulatory issues falling within its remit. I do The CIGD prepared the terms of reference believe that we have progressed and are and the Authority applied for a project under progressing in the right direction. All these the 2006 Transition Facility to enable it to fully activities - the ones reported today - are just meet its obligations arising from the Acquis the tip of the iceberg. However, we are now Communautaire in relation to the Motor doing our best to try to move the whole Vehicles Type Approval regime. The project iceberg forward! fiche proposing the light twinning project was approved during the current year and its ANNUAL REPORT 2005-06

Foodstuffs, Chemicals, and Cosmetics Directorate

Mr. Martin Seychell

The Malta Standards Authority Act provides for the A set of new restrictions on the marketing and use of establishment of independent Directorates through which dangerous substances were published as L.N. 153/2006 the Authority shall exercise its functions. The Foodstuffs, on 30 June 2006. These new restrictions concerned the Chemicals and Cosmetics Directorate was established use of toluene in spray paints and adhesives intended in October 2000 through Legal Notice 213 of 2000. This for sale to the general public polycyclic aromatic Legal Notice also established the responsibilities of the hydrocarbons (PAHs) in extender oils used in vehicle Directorate. tyres and phthalates in toys and childcare articles.

The sectors falling within the scope of this Directorate (B) FOODSTUFFS are the following: An amendment to the Food Supplements Regulations (a) Foodstuffs, including source materials was published as L.N. 327/2005 on 4 October 2005. This (b) Water amendment permitted the sale of food supplements (c) Alcoholic beverages containing levels of vitamin B6 and retinol exceeding (d) Fertilizers and feeding stuffs (only with regards guidance levels, subject to conditions that may be imposed to risk assessment for GMO products and by the Food Safety Commission. This amendment was certain additives) necessary in order to ensure a smooth interface between (e) Chemical substances, products and legislation on food supplements and that governing preparations medicinal products, while minimising the administrative (f) Medicinal products (with regards to vitamins / burden on importers. minerals and herbals not considered as medicinals, and to borderline products where The Materials in Contact with Food Regulations were discussions with the Medicines Authority are substantially amended by L.N. 338 of 2005 and L.N. 226 required) of 2006. (g) Cosmetic products (h) Textiles and footwear L.N. 339 of 2005 amended the Labelling Regulations, (i) Glass, wood, paper and metal products so as to temporarily exclude certain ingredients from the (j) Packaging material allergen declaration requirement, pending further evaluation by the European Food Safety Authority. 1. Legislation Official methods for the sampling and analysis of (A) CHEMICALS & COSMETICS foodstuffs for the determination of various contaminants A number of technical adaptations to the Cosmetic in foods were published as L.N. 60 of 2006 and L.N. 107 Products Regulations were published during the year. of 2006. These methods aim at standardizing laboratory L.N. 16/2006 prohibited the use of a number of hair dyes test and sampling methods. for which evidence of safety had not been submitted by the cosmetics industry. L.N. 220/2006 amended the Second and Third Schedules to the main Regulations in accordance with the latest adaptations to Directive 76/768/EEC.

Malta Standards Authority 14-15 www.msa.org.mt

2. Other Activities During the period under review, the Directorate continued its preparations for the During the past year, the Directorate introduction of the new EC system for the intensified its contacts with local economic registration, authorisation and evaluation of operators and provided assistance free of chemicals (REACH). MSA held a number of charge. The most common requests for meetings with the Malta Federation of assistance and information concerned the Industries as well as with other regulatory labelling of foodstuffs, HACCP, permitted authorities before finalising its additives, nutritional and health claims, and recommendations to the Ministry for cosmetic products. A number of foreign Competitiveness and Communications on manufacturers and exporters also sought this proposal. MSA has also drafted an interim guidance from the Directorate regarding strategy aimed at assisting local users of Maltese legislative requirements. MSA also chemicals to prepare for registration, as well received a total of 442 notifications of food as to identify substances that will require supplements placed on the Maltese market authorisation, with a view to either controlling between September 2005 and September the associated risks or operating a substitution 2006, bringing the total of notified food policy. supplements on the Maltese market to 1268.

On the other hand, as of 30 September 2006, Malta continued to play a very active role in 315 cosmetic products have been notified to the discussions on the REACH proposal at MSA after having been first placed on the EU level. This proposal has been described Community market in Malta. No new chemical as one of the most important Community substances have so far been notified. legislative proposals in recent years and will certainly have a major impact on all In August 2006, the first formal application businesses using chemicals in one form or for a Protected Designation of Origin (PDO) another. Malta’s attention has been primarily under EC Regulation 510/2006 was received focused on low volume substances, by MSA. This application concerns Lumilaring where the Commission’s work on impact ta’ Ghawdex. Directorate staff has also been assessment has shown particular vulnerability carrying out work in connection with to the registration costs of REACH. certification of local organic produce. As part of the practical preparations for The Directorate was and still is involved, REACH, attention is also being paid to along with the Standardization Directorate, developing the necessary administrative in the certification of organic farming practices capacity. MSA has concluded a twinning according to EC Regulation 2092/91. The light agreement with the Austrian FCCD staff act as the technical experts during Umweltbundesamt (Environmental Agency) the audits. In the area of food safety, the for further training of MSA staff in toxicology Directorate is represented on the Food Safety and ecotoxicology. Commission established by the Minister of Health. During 2005, the Directorate finalised work on the adoption of a Guide to Good Hygiene Practice for the Catering Sector. ANNUAL REPORT 2005-06

Significant EU funding having been provided through Transition Funding to the tune of EUR 439,000 has been fully tendered for and awarded in 2006. The lots of equipment consisted of mass standards to a cumulative weight of 30tonnes and which will be the traceable source for the calibration of large weighing systems and weigh bridges, mass comparators up to 1tonne to allow dissemination of mass scale from the national 1kg and the establishment of a primary humidity standard.

The complement of equipment will be fully delivered Ing. Joseph Bartolo and commissioned by March 2007. In conjunction with this acquisition of equipment the Maltese Government is investing EUR 74,000 into the refurbishing of the adjacent site to that currently occupied by MSA-NMS which will increase the labs footprint by 30% and accommodate the larger comparators and handling Metrology equipment necessary. Training in the area of humidity has also been Directorate undertaken by the lab’s staff, at the Spanish National Metrology Institute in the field of humidity, INTA. This training was also funded by the Transition Facility funding supplied for improving market surveillance. The labs have continued to develop their portfolio of The core business has increasingly become a support for manufacturing industry in the area of temperature services together with meeting and mass. Over 400 calibration certificates have been the demands of an ever issued in the last year and around 55% of work load increasing client list. The was in the field of temperature, with 45% in the field of mass and 5% for dimension. Pricing in all areas is economic sustainability of the competitively placed, at par or better than other service has been maintained, European accredited labs. with revenue generated through calibration services balancing off recurrent costs. The pricing levels have been maintained at the same levels from the year before while minimizing the impact of increased power costs and increasing work throughput through higher efficiencies.

Malta Standards Authority 16-17 www.msa.org.mt

The diversification in the area of temperature has Final reporting in this inter-comparison is due in seen MSA-NMS conduct a large variety of on site the last quarter of 2006. After training received in calibrations. The remit is being developed to allow INTA, the competencies attained in the field are to the labs to provide an increasing array of calibration be tested through a bilateral with the training capabilities with large manufacturing firms actively laboratory. subcontracting calibration requirements to NMS in lieu of setting up in house calibration capability. MSA-NMS has also done its share in bringing to Malta various committee and work group meetings The current limitation for expansion of further to Malta, namely WG2, and WG5 from Welmec services is the human resource availability which together with the Technical Committee for Quality is proposed to be ameliorated in 2007. from Euromet. This interaction with high level working groups further enhances our understanding An important component in maintaining the highest of current thinking in the areas of scientific and levels of competency is through the participation legal metrology. in international inter-comparisons. MSA-NMS is currently running two important sets of experiments, MSA-NMS is a lean organisation with the motivation the first in the field of mass sees us characterising and flexibility to assist all players in local industries all our mass comparators and establishing our to enhance their competitiveness by making measurements from 1mg to 10kg at E2 level. In available competencies, equipment and stable the area of dimension measurement MSA-NMS is measurement environments critical for high order co-piloting with NPL a varied set of block gauge measurements. using mechanical measurement methods. ANNUAL REPORT 2005-06 Standardization Directorate

Dialogue is our Success

Most Maltese enterprises rely more or less on standards. One of the greatest contributions of MSA to society no doubt relates to its function as the national standards body. This function is invested within the Standardization Directorate of MSA. The period of this report continued to be a time of expansion of standardization activities. The Standardization Directorate worked to prepare for market’s and stakeholders’ changing demand in particular greater participation in standardization activities, certification and the dissemination Ing. Francis Farrugia of information on national, European and international standardization activities.

The mission of MSA is based on the awareness of having co-responsibility for a sustainable development in society. Key aspects of MSA performance relate to the economic, social and environmental aspects. NUMBER OF ADOPTED STANDARDS Stakeholder dialogue is the key to our success (OCT 05 - SEP 06) Standardization is based on a close dialogue with stakeholders. Standardization work 2500 is in itself a dialogue and consensus process with the participation of authorities, trade organisations, NGOs, the corporate sector and our employees. 2030 2000 A large number of dialogue forums, involving both external and internal stakeholders take place. MSA seeks to ensure that the widest possible group of stakeholders have influence on and participate in standardization. To ensure this MSA makes it possible 1500 for participants to apply for free participation in standardization committees (see insert of active standardization committees). 1000 497 Our active committees 500 80 NATIONAL COMMITTEE NUMBER OF MEMBERS

0 Board of Standards 12 ETSI CENELEC CEN IEC/CENELEC National Committee 7 ETSI National Committee 8 National Committee for the Environment 9 MSA/TC329 WG4 - Language Study Tours 6 MSA/TC 138 - Translation Services 12 MSA/TC 156 - Occupational Health & Safety 10 MSA/TC 250- Eurocodes 9 In relation to existing MSA/TC 19- Petroleum Products 3 stakeholders, the MSA/ISO TC 37 - Language Resources 10 Standardization Directorate MSA/200- Maltese Locale 6 aims is to retain and expand MSA TC 346 - Cultural Heritage 11 collaboration by identifying their MSA/TC 1000- Food Hygiene 20 needs and expectations, and to MSA/TC 329 WG 3 - Recreational Diving Services 3 ensure that their feedback is MSA/TC 1200 - Smoking in Public Places / Ventilation in industrial premises 12 included in MSA’s business MSA/TC 1400 - Motor Vehicles Repairs 10 development plans. As regards MSA/TC 800 - Colour Coding of Waste Recipients 7 new stakeholders, the policy is MSA/CEN TC 329 WG 5 - Tourist Guides 7 to identify their needs for MSA/CEN TC 800 - Degradable Plastics 12 cooperation on new services, MSA/CEN TC 1600 - Remote Gaming 9 advisory projects or for MSA/CEN TC 10 - Lifts 8 influence via participation in MSA TC 228 Tourism and related Services 5 existing formal dialogue forums and in standardization TOTAL - 21 COMMITTEES committees.

Malta Standards Authority 18-19 www.msa.org.mt Our services:

STANDARDS DEVELOPMENT - By virtue of its founding Gaia Foundation - Ghjn Tuffieha law, the MSA is the sole entity in Malta empowered to develop Mario Grech - Xagha Gozo and publish Maltese Standards following international Josephine Humphreys - Siggiewi standards writing practices through Technical Committees. Joseph Sciberras - Mellieha

STANDARDS ADOPTION - The MSA Act empowers the Several studies that have been made show the direct value Standardization Directorate to adopt regional and international of certification to enterprises and society. MSA certification standards as Maltese Standards following internationally activities helps to add value for Maltese trade and industry, accepted practices. For the last year, 2607 European among other things through the financial opportunities a standards have been adopted as Maltese standards (see certification can open for an enterprise. insert graph). The total number of standards and amendments in the MSA catalogue now counts 20,567. In the area of certification MSA is continuously listening and reacting to stakeholders’ opinions. MSA is fine-tuning its SALE OF STANDARDS - The Standardization Directorate services and organisation so that it can meet the developing provides access and sale of all Maltese, European and demands and needs of industry and other organisations international standards. which are: • Addressing the increasing demand of Maltese economic INFORMATION SERVICES - Information on national, players for certification services; European and international standards are provided to the • Developing staff competences in relation the market’s public through the Directorate’s library facilities. needs and expectations; • Increasing the information dissemination effort; TRAINING COURSES - General and tailor-made courses • Obtaining international recognition of MSA certification on standardization and certification processes are provided services. on a regular basis by MSA. CUSTOMER SATISFACTION CERTIFICATION - 18 organizations have been certified MSA dialogue with customers takes place at several levels. against MSA EN ISO 9001:2000 and against Council MSA conducts customer satisfaction surveys for all the Regulation (EEC) No. 2092/91 on organic farming practices services it provides. (see insert list of certified organisations. Based on the outcome of the customer surveys in 2005 it ORGANISATIONS CERTIFIED BY MSA TO MSA EN ISO has been generally found that customers are satisfied with 9001:2000 MSA collaboration. However, it is also realized that customers Internal Audit Unit, Maltacom Plc. (whether they are from the public or private sector) are Advanced Industrial Supplies Ltd. increasingly demanding more information and service. When Rapco Ltd. necessary MSA enters into an individual dialogue with London Forfaiting Company Ltd. stakeholders so as to carefully evaluate their demands in FM Environmental Malta Ltd. order to develop its services and itself. Metal Finishing Technology Ltd. U.C.I.M. Co. Ltd. MSA is a knowledge enterprise. The professional qualifications Electronic Products Ltd. of its staff and its ability to attract and retain competent Playmobil Malta Ltd. employees are crucial. Within its limited resources MSA takes great care to be an attractive workplace and a socially ORGANISATIONS CERTIFIED BY MSA TO COUNCIL responsible enterprise. The years ahead will involve a REGULATION (EEC) NO. 2092/91 (Organic Farming) substantial development of the standardization activities, Mary Mallia - Mgarr processes and services and the interaction of MSA with Ministry of Rural Affairs and the Environment - national and international standardization partners, such as Ghammieri Farm greater collaborations among the members of the European Wigi Farrugia - Xewkija Gozo standards bodies CEN, CENELEC and ETSI so as to Joseph Borg - San Gann safeguard better Maltese interests in standardization. Ruben Curmi - Xewkija Gozo ANNUAL REPORT 2005-06

Report and financial statements For the year ended 30 September 2006

22 Report of the council members 23 Report of the auditors to the council members Table of 24 Income and expenditure account 25 Balance sheet Contents 26 Statement of changes in net assets/equity 26 Cash flow statement 27 Notes to the financial statements

Malta Standards Authority 20-21 www.msa.org.mt

Report of the council members

Principal Activities The Malta Standards Authority (MSA) is an autonomous institution established by virtue of the Malta Standards Authority Act (Cap. 419 of the Laws of Malta).

The Authority is governed by a Council consisting of a Chairman and fourteen members. The Authority is entrusted with the coordination of standardisation and related activities in Malta. It also promotes the adoption and application of metrology and accreditation and offers technological advice and consultancy services to government agencies as well as private sector organisations.

Responsibilities of the Council Members The Council is responsible amongst others to prepare an annual report on the work of the Authority during the preceding year. This entails responsibility to ensure that:

a. Proper accounting records are kept of all transactions entered into by the Authority, and of its assets and liabilities; b. Adequate controls and procedures are in place for safeguarding the assets of the Authority, and the prevention and detection of fraud and other irregularities.

In preparing the financial statements which give a true and fair view of the state of affairs as at the end of each financial year and of its surplus or deficit for that year, the Council:

- selects suitable accounting policies and then applies them consistently; - makes judgements and estimates that are reasonable and prudent; - follows International Financial Reporting Standards; - prepares the financial statements on the going concern basis unless this is considered inappropriate.

Negative Result due to Underfunding The results for the year under review show a deficit of Lm31,117.

It is envisaged that the current expenditure for the coming year will have to be covered by an increase in the Government contribution.

Chairman Council Member

23 October 2006 ANNUAL REPORT 2005-06

Report of the auditors to the council members

We have audited the accompanying financial statements on pages 3 to 13. These financial statements are the responsibility of the Authority. Our responsibility is to express an opinion on these financial statements based on our audit.

We conducted our audit in accordance with International Standards on Auditing. Those Standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by the Council, as well as evaluating the overall financial statement presentation. We believe that our audit provides a reasonable basis for our opinion.

In our opinion, the financial statements give a true and fair view of the state of affairs of the Authority as at 30 September 2006 and of its deficit, changes in net assets/equity and cash flows for the year then ended in accordance with International Financial Reporting Standards and have been properly prepared in accordance with the Malta Standards Authority Act, 2000.

Mark Bugeja f/Grant Thornton

Certified Public Accountants

Grant Thornton House Princess Elizabeth Street Ta’ Xbiex MSD 11 Malta

23 October 2006

Malta Standards Authority 22-23 www.msa.org.mt

Income and Expenditure Account for the year ended 30th September 2006

2006 2005 Note Lm Lm Income Government contribution 285,650 299,500 Government grant 56,041 82,747 Pre-accession funds 3 - 67,237 Other 4 204,232 91,494

545,923 540,978 Expenditure Administrative and other expenses (577,040) (551,187)

Deficit for the year 5 (31,117) (10,209) ANNUAL REPORT 2005-06

Balance Sheet at 30th September 2006

2006 2005 Note Lm Lm Non-current assets Plant and equipment 6 459,582 474,223 Intangible asset 7 13,875 18,500

473,457 492,723

Current assets Debtors 8 18,481 20,607 Cash at bank and in hand 12,133 10,191

30,614 30,798 Creditors: amounts falling due within one year 9 (81,425) (92,717)

Net current liabilities (50,811) (61,919)

Total assets less current liabilities 422,646 430,804

Creditors: amounts falling due after more than one year 10 (386,118) (363,159)

Net assets 36,528 67,645

Reserves Retained funds 36,528 67,645

The financial statements on pages 24 to 30 were approved on 23 October 2006 and were signed by:

Chairman Council Member

Malta Standards Authority 24-25 www.msa.org.mt

Statement of changes in net assets / equity for the year ended 30th September 2006

Retained funds Lm At 30 September 2004 77,854 Deficit for the year (10,209)

At 30 September 2005 67,645 Deficit for the year (31,117)

At 30 September 2006 36,528

Cash Flow Statement for the year ended 30th September 2006

2006 2005 Note Lm Lm Operating activities Cash generated from/(absorbed by) operations 11(a) 1,758 (16,446)

Investing activities Payments to acquire plant and equipment 11(b) (71,614) (2,976) Interest received 184 237

Net cash used in investing activities (71,430) (2,739)

Financing activities Proceeds from government 71,614 1,510

Net increase/(decrease) in cash at bank and in hand 1,942 (17,675) Cash at bank and in hand at beginning of year 10,191 27,866

Cash at bank and in hand at end of year 12,133 10,191 ANNUAL REPORT 2005-06

Notes to the Financial Statements

1 Presentation of financial statements

The financial statements have been prepared in accordance with International Financial Reporting Standards (IFRS).

These financial statements are presented in Maltese Liri (Lm).

2 Summary of significant accounting policies

The financial statements have been prepared on the historical cost basis. The principal accounting policies are set out below.

Revenue recognition Government contributions are recognised as income when received.

Government grants represent amounts received in terms of capital votes. Government grants received in respect of expenditure charged to the income and expenditure account during the year have been included in the income and expenditure account. The remainder are deferred and are included in the income and expenditure account by instalments over the expected useful lives of the related assets.

Pre-accession funds represent income received in accordance with the ‘project fiche’ agreement signed between the Government of Malta and the European Union. Funds received or paid on behalf of the Authority in respect of expenditure charged to the income and expenditure account during the year have been included in the income and expenditure account. Funds paid on behalf of the Authority in respect of capital expenditure are deferred and included in the income and expenditure account by instalments over the expected useful lives of the related assets.

Interest income is accrued on a time basis, by reference to the principal outstanding and at the interest rate applicable.

Plant and equipment Items of plant and equipment are stated at cost less accumulated depreciation.

Depreciation is charged so as to write off the cost of assets over their estimated useful lives, using the straight line method, on the following bases: % Improvements to premises 2 Computer equipment 33 Equipment, furniture and fittings 15 Metrology equipment 33 Motor vehicles 20

No depreciation is provided on assets that are not yet brought into use.

Intangible asset Intangible assets are measured initially at purchase cost and amortised on a straight-line basis over their estimated useful lives which is on average 8 years.

Impairment At each balance sheet date the Authority reviews the carrying amounts of its assets to determine whether there is any indication that those assets have suffered an impairment loss. If any such indication exists, the recoverable amount of the asset is estimated in order to determine the extent of the impairment loss (if any).

If the recoverable amount of an asset is estimated to be less than its carrying amount, the carrying amount of the asset is reduced to its recoverable amount. Impairment losses are recognised as an expense immediately. Where an impairment loss subsequently reverses, the carrying amount of the asset is increased to the revised estimate of its recoverable amount, but so that the increased carrying amount does not exceed the carrying amount that would have been determined had no impairment loss been recognised for the asset in prior years. A reversal of an impairment loss is recognised as income immediately.

Trade and other debtors Trade and other debtors are stated at their nominal value as reduced by appropriate allowances for estimated irrecoverable amounts.

Trade and other creditors Trade and other creditors are stated at their nominal value.

Malta Standards Authority 26-27 www.msa.org.mt

Notes to the Financial Statements

Financial Instruments Financial assets and financial liabilities are recognized on the company’s balance sheet when the company has become a party to the contractual provision of the instruments.

Foreign currency amounts Assets and liabilities in foreign currencies are translated into Maltese Liri at the rate of exchange ruling at the balance sheet date.

Transactions during the period are translated into Maltese Liri at the rate of exchange ruling on the date of the transaction.

All profits and losses on exchange are dealt with through the income and expenditure account. Malta Standards Authority - Report and financial statements for the year ended

3 Pre-accession funds 2006 2005 Lm Lm

Technical assistance and training equipment - 67,237

4 Other income 2006 2005 Lm Lm

Gross profit from sale of standards 16,050 7,002 Bank interest 184 237 Income from seminars 1,465 4,975 Income from translation of standards 2,897 - Income from CEN contracts 9,275 - Miscellaneous 3,683 5,102 Calibration services 17,907 16,218 Certification services 6,210 4,545 Application accreditation fee 5,128 1,925 Assessment application fee 3,525 8,560 Surveillance accreditation fee 1,741 - Income re EU Project financed by Malta Government 17,172 17,172 Income re EU Project financed by EU 118,995 25,758

204,232 91,494

5 Deficit for the year 2006 2005 Lm Lm Deficit for the year is stated after charging: Council members’ remuneration 10,500 14,700 Staff costs 194,345 197,000 Auditors’ remuneration 300 300 Depreciation of plant and equipment 86,255 72,103 Amortisation of intangible fixed asset 4,625 4,625 ANNUAL REPORT 2005-06

Notes to the Financial Statements

6 Plant and equipment Equipment, Improvements Computer furniture Metrology Motor to premises equipment & fittings equipment vehicles Total Lm Lm Lm LmLm Lm Cost At 1 October 2005 272,073 57,562 196,268 213,269 43,513 782,685 Additions - 9,713 - 61,901 - 71,614

At 30 September 2006 272,073 67,275 196,268 275,170 43,513 854,299

Depreciation At 1 October 2005 33,189 55,070 144,138 54,377 21,688 308,462 Charge for the year 5,344 4,756 23,853 31,877 20,425 86,255

At 30 September 2006 38,533 59,826 167,991 86,254 42,113 394,717

Net book value At 30 September 2006 233,540 7,449 28,277 188,916 1,400 459,582

At 30 September 2005 238,884 2,492 52,130 158,892 21,825 474,223

Equipment, furniture and fittings include furniture and equipment with a net book value of Lm 5,731 currently being used by the Malta National Laboratory. These tangible assets shall be transferred to this separate entity in due course.

7 Intangible asset Library publications Lm Cost At 1 October 2005/30 September 2006 37,000

Amortisation At 1 October 2005 18,500 Charge for the year 4,625

At 30 September 2006 23,125

Net book value At 30 September 2006 13,875

At 30 September 2005 18,500

8 Debtors 2006 2005 Lm Lm Amounts falling due within one year: Trade debtors 8,713 8,548 Other debtors 296 2,330 Prepayments and accrued income 9,472 9,729

18,481 20,607

9 Creditors: amounts falling due within one year 2006 2005 Lm Lm Trade creditors 14,565 13,465 Other creditors 5,181 8,084 Deferred Government grants (refer to note 10) 56,041 63,250 Accruals 5,638 7,918

81,425 92,717

Malta Standards Authority 28-29 www.msa.org.mt

Notes to the Financial Statements

10 Creditors: amounts falling due after more than one year 2006 2005 Lm Lm Deferred Government grants (note) 442,159 426,409 Less: amounts to be transferred to income and expenditure within one year (56,041) (63,250)

386,118 363,159

Note - Government grants European National Metrology ICT Union Laboratory Equipment Laboratory Operational Grant Vote Vote Grants Allocation Total Lm Lm Lm Lm Lm Lm Cost At 1 October 2005 72,417 360,565 161,007 213,919 - 807,908 Amounts granted during the year - - 177 70,869 745 71,791

At 30 September 2006 72,417 360,565 161,184 284,788 745 879,699

Amortisation At 1 October 2005 71,283 145,427 110,412 54,377 - 381,499 Amounts transferred to income and expenditure during the year 504 17,984 9,496 27,871 186 56,041

At 30 September 2006 71,787 163,411 119,908 82,248 186 437,540

Balance At 30 September 2006 630 197,154 41,276 202,540 559 442,159

At 30 September 2005 1,134 215,138 50,595 159,542 - 426,409

11 Notes to the cash flow statement (a) Cash generated from/(absorbed by) operations 2006 2005 Lm Lm Deficit for the year (31,117) (10,209) Adjustments for: Depreciation 86,255 72,103 Amortisation 4,625 4,625 Government grant transferred to income and expenditure account (56,041) (63,250) Interest receivable (184) (237) Amount released on transfer of asset to MNL - (19,497)

Surplus/(deficit) before working capital changes 3,538 (16,465) Decrease in debtors 2,126 6,921 Decrease in creditors (3,906) (6,902)

1,758 (16,446)

(b) Plant and equipment During the year, the Authority acquired plant and equipment with an aggregate cost of Lm 71,614 which were all paid through a government grant.

12 Contingent liabilities 2006 2005 Lm Lm

Invoices in dispute 3,516 3,516 ANNUAL REPORT 2005-06

Income and expenditure account

Page 2006 2005 Lm Lm Income Government contribution 285,650 299,500 Government grant 56,041 82,747 Gross profit from sale of standards (Below) 16,050 7,002 Bank interest 184 237 Income from seminars 1,465 4,975 Income from translation of standards 2,898 - EU projects funded by Malta Government 17,172 17,17 2 EU projects funded from EU funds 118,995 25,758 Other income 47,468 36,350 Pre-accession funding: - Training and technical assistance - 67,237

545,923 540,978 Expenditure Administrative and other expenses (32) (577,040) (551,187)

Deficit for the year (31,117) (10,209)

Trading account - Standards

2006 2005 Lm Lm

Sale of standards 18,515 8,247

Cost of sales Purchase of standards (2,465) (1,245)

Gross profit (Above) 16,050 7,002

Malta Standards Authority 30-31 www.msa.org.mt

Income and expenditure account schedule

Page 2006 2005 Lm Lm Administrative and other expenses Council members’ remuneration 10,500 14,700 Salaries 194,345 197,000 Technical committees - 4,672 Membership fees 46,327 41,357 Seminar costs 482 3,022 Training and technical assistance funded by pre-accession funds - 67,237 Training funded by transition facility 2004 project 92,933 - Local training 351 - Telecommunications 5,129 5,189 Water and electricity MSA 7,980 9,559 Water and electricity MNL - 9,749 Insurance 3,224 2,136 Rent 11,932 11,932 Printing and stationery 1,629 3,464 Postage and couriers 677 1,396 Publications 330 300 Repairs and maintenance 1,426 2,332 Cleaning expenses 1,389 1,540 Legal and professional fees 6,975 3,623 Auditors’ remuneration 300 300 General expenses 487 497 Depreciation 86,255 72,103 Amortisation 4,625 4,625 Advertising 1,755 1,590 Travelling 34,080 28,162 Transport 5,072 4,258 Hospitality and entertainment 367 674 Bank interest and charges 63 72 Hire of equipment 896 1,480 Metrology lab loose purchases 949 661 Subscriptions 660 865 Realised loss on exchange 8 - Accreditation cost 4,209 5,424 Certification cost 330 78 EU project cost 51,355 51,190

(31) 577,040 551,187