REACH Notification - Substances Of Very High Concern

The Registration, Evaluation, Authorisation and Restriction of Chemicals Legislation (REACH)

On 18 December 2006, the European Commission passed REGULATION (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, and amending and repealing some earlier chemicals regulations and directives in order to ensure a high level of protection of human health and the environment as well as the free movement of substances, on their own, in preparations and in articles, while enhancing competitiveness and innovation. This Regulation is also aimed at promoting the development of alternative methods for the assessment of hazards of substances.

REACH is pursuant to the implementation plan adopted on 4 September 2002 at the Johannesburg World Summit on sustainable development, according to which the European Union is aiming to achieve that, by 2020, chemicals are produced and used in ways that lead to the minimisation of significant adverse effects on human health and the environment.

The REACH notifications and analyses are aimed at generating information on substances and their uses. By the mandate given in the Article 14 of the Regulation 1907/2006, information generated is also expected to be used by community voluntary instruments such as the eco-labelling scheme (The EU flower Logo). The Commission should consider in the review and development of relevant Community legislation and voluntary instruments how information generated by this Regulation should be used, and examine possibilities for establishing a European quality mark.

REACH Notification on Substances of Very High Concern

REACH regulations continue to pose questions. Here we look at substances of very high concern (SVHCs). Notification of SVHC is required when present in articles:

Article 7 of REACH details the criteria under which an SVHC would need to be notified to the European Chemicals Agency (ECHA) if it is present in an article. Notification would be required if:

(a) The substance is present in those articles in quantities totalling over 1 tonne per producer or importer per year, and;

(b) The substance is present in those articles above a concentration of 0.1 % weight by weight of the article (not homogeneous material as with RoHS). Notification is not required, however, if the producer or importer can exclude exposure to humans or the environment during normal or reasonably foreseeable conditions of use including disposal. (In such cases, the producer or importer shall supply appropriate instructions to the recipient of the article.) or, if the substance has already been registered for that use.

The SVHC's that may require notification will be named on the so called 'candidate list' - this doesn't exist yet, but should be published on the European Chemical Agency's (ECHA) website towards the end of this year or, more likely, early next year. Such notifications will not be required until June 2011 at the earliest.

Authorisation:

Substances that require authorisation will be published as Annex XIV of REACH. This will be developed from a list of proposed substances for authorisation which will be drawn from the "candidate list" mentioned above, but is likely to be much smaller. This proposed list will be published on the ECHA website by June 2009. If a substance eventually appears on Annex XIV it will require authorisation irrespective of the tonnages involved.

Any substance that falls into this category will require a safety data sheet to be provided to all the recipients of the substance or preparation containing the substance.

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=oj:l:2006:396:0001:0849:en:pdf

(Amendments) http://eur-lex.europa.eu/LexUriServ/LexUriServ.do? uri=OJ:L:2007:136:0003:0280:EN:PDF

REACH fees

Registration and, in particular, authorisation of substances under the REACH Regulations can be a costly business.

After considerable debate the fees have now been published and entered into force on 20/4/08.

Registration is required where a substance is imported or manufactured in quantities starting at one tonne or more per annum (1 tpa) in the European Union. Registration can be individual or, where the same substance is used, via a consortium.

Manufacturers outside the EU will have the option of appointing an importer or "only representative" to act on their behalf.

Pre-registration, which is free, for substances already on the market, known as "phase-in" substances, started on 1/6/08 and the window will remain open for six months.

There is a significant range of costs with, for example, the standard individual registration cost for 1 to 10 tpa standing at €1600 through to €31000 for 1000 tonnes or more.

Considerable discount on this standard rate is on offer for companies defined as medium, small or micro enterprises. As an example, a small enterprise would only pay 40% of the standard rate.

However, where substances of concern require authorisation of use, the standard charge starts at €50,000 reducing to €25,000 for a small, and €7,500 for a micro enterprise.

Fees will be adjusted in line with inflation from June 2009. http://eur-lex.europa.eu/LexUriServ/LexUriServ.do? uri=OJ:L:2008:107:0006:0025:EN:PDF http://www.reach-compliance.eu/english/finances/REACH-Fees.html

RoHS v REACH approach to risk

The basis for RoHS and REACH substance restrictions are quite different. RoHS restrictions are based on hazards - if a substance is hazardous and there are alternatives, then it could be banned. REACH restrictions are introduced only if a risk to human health or the environment can be proven, it cannot be controlled and substitutes exist.

RoHS restrictions can be imposed without a full assessment of the impact of the possible alternatives. It is enough to show that there is a potential risk without evidence of an actual risk.

For example, lead is banned by RoHS but there is no evidence that its presence in electronics has or is harming human health or the environment. Also, the possible substitutes had not been identified when this restriction was imposed in 2002 and although less hazardous substitute solder alloys have since been found, their impact was not known until some years after the RoHS lead ban.

The impact of lead solder substitutes is now known because the US EPA carried out a life cycle assessment which shows that neither lead solders nor lead-free solders are clear "winners" overall as they each have different impacts.

REACH restrictions are based on lengthy risk assessments that consider research into the impact of the substance in its entire life cycle and also the possible alternatives. This also considers the control measures used by industry to minimise risk and social and economic issues. REACH restrictions are likely to be application specific where a risk is identified although total bans are also possible.

The other main difference is that RoHS bans substances present in electrical equipment that is within the scope of this directive. REACH affects all chemicals including those used to make the equipment (alloys, solvents, paints, etc.) and chemicals present in finished products of all types. There are very few exclusions and exemptions. http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=oj:l:2006:396:0001:0849:en:pdf

REACH pre registration - up and running

From 1/6/08 "pre-registration" of substances manufactured or imported in quantities of 1 tonne or more per annum (known as "phase-in" substances) will be possible for a window of 6 months.

Doing so will ensure that the chemical will be considered as part of a staggered assessment and full registration programme starting with the highest volumes, over 1,000 tonnes per annum, and most hazardous substances first. These will need to be registered, with the appropriate level of technical data, by November 2010 ranging through to the lowest threshold of 1 to 100 tonnes per annum that require registration by May 2018.

Failure to pre-register means that the substance cannot be manufactured or put on the market until it has been registered with the required data.

After the first couple of weeks of pre-registrations the European Chemicals Agency (ECHA) based in Helsinki reports that 1,150 legal entities have signed up from EU Member States. There have been 5,460 pre-registrations with 40% of those from Germany, 26% from the UK and 7% from both France and Spain.

Pre-registration is optional but failure to do so means that after 1/12/08 the substance will be considered as a non phase-in and the requirement to register becomes immediate, along with the submission of a comprehensive technical dossier. ECHA consults on REACH SVHCs

The European Chemicals Agency (ECHA) has published a first draft of substances that could eventually lead to tough authorisation requirements that will potentially prohibit their use unless industry can indicate there is a compelling reason to allow them. Each entry on the so called "candidate list" of substances of very high concern (SVHCs) has been put forward by a government in the European Union. The list includes three phthalates and the brominated flame retardant HBCDD.

The ECHA has opened a public consultation on the list - the first to be held around the operation and implementation of the REACH Regulations - in which stakeholders will be encouraged to submit information on use and exposure as well as on safer alternative substances. Comments should be confined to technical issues.

After the consultation closes on 14 August 2008, the ECHA Member State Committee will review the dossiers on which comments have been received and propose substances to be placed on the candidates list. The agency hopes to publish a final list by the end of October. It will be updated on a regular basis as more information on other substances accumulates under the REACH registration process.

Where a substance is included on the candidate list it will generate various requirements for producers, importers and suppliers of articles that contain it. A second consultation will lead to a decision on whether or not the substance should undergo authorisation.

The 16 substances on the list are anthracene, 4,4'-diaminodiphenylmethane, dibutyl phthalate (DBP), cyclododecane, cobalt dichloride, diarsenic pentaoxide, diarsenic trioxide sodium dichromate, musk xylene, DEHP, Hexabromocyclododecane (HBCDD), short chain chlorinated paraffins (SCCPs), bis(tributyltin)oxide, lead hydrogen arsenate, triethyl arsenate and benzyl butyl phthalate (BBP). http://echa.europa.eu/consultations/authorisation/svhc/svhc_cons_en.asp http://echa.europa.eu/doc/press/pr_08_18_pub_consultations_20080630.pdf

Proposals for inclusion of substances in the Candidate List kick off ECHA’s public consultations

ECHA/PR/08/18 : From 30 June until 14 August 2008, interested parties can submit scientific comments on the proposals that were submitted by Member States competent authorities to ECHA in the form of Annex XV dossiers. Comments should relate to the hazardous properties of the substances that qualify them as SVHCs. Interested parties are also invited to submit information on use and exposure as well as on safer alternative substances and techniques. After the consultation period, ECHA's Member State Committee will review the dossiers on which comments were received from interested parties, other Member States or the Agency. If the Member State Committee agrees that the substances fulfil the criteria for SVHC, ECHA will place them on the so-called ‘candidate list’. Substances appearing on this ‘candidate list’ may eventually be included in the list of those subject to authorisation (Annex XIV of REACH or ‘authorisation list’). The ‘candidate list’ will be published on ECHA’s web site and regularly updated when new substances have been identified as SVHC. ECHA plans to publish the first list by the end of October 2008. The placement on the candidate list will trigger new duties for producers, importers and suppliers of articles. Producers and importers of articles that contain substances that are included in the ‘candidate list’ have, under certain conditions, an obligation to make a notification to ECHA. Likewise, suppliers of articles will need to provide to their customers and consumers available information on the safe use of their articles containing these substances. The substances on the ‘candidate list’ may eventually be included in the ‘authorisation list’. During a process of prioritising substances for this purpose, interested parties will again be invited to submit comments. Once a substance is included in the ‘authorisation list’ its use will be subject to authorisation. Companies wishing to market or use such a substance will have to submit an application for authorisation to ECHA. Decisions on authorisations will be made by the European Commission. Other types of public consultations are expected to be launched later this year on proposals for tests involving vertebrate animals and on proposals for harmonised classification and labelling. Categories 8 and 9: In or not so sure?

Article 6 of 2002/95/EC RoHS (Restriction of Hazardous Substances) Directive requires the European Commission (EC) to carry out a review of the directive within four years of its adoption. The main issues include: o The possibility of including categories 8 (medical devices) and 9 (monitoring and control instruments) of the WEEE (Waste Electrical and Electronic Equipment) Directive within the scope of RoHS o The possibility of restricting more substances that are hazardous, are used in significant quantities and where there are suitable substitutes o All of the existing exemptions to be reviewed and may be either modified, be more restrictive or removed completely o Other aspects such as where definitions and scope are unclear, as well as the subject of enforcement

ERA Technology, based in Surrey UK, examined whether or not it would be possible to include categories 8 and 9 within scope. Their conclusion was yes but with several observations:

o There would be a need for many more exemptions o There was a danger of stifling innovation if it was done wrong (e.g. inhibiting the development of novel sensors using restricted substances, the use of which far outweighs the small amounts used) o These are relatively slow moving industries in terms of design cycles. If a restriction was brought in too early it could force products off the market early, damaging industry and affecting users such as hospitals, patients etc. o The rapid introduction of a restriction would put an enormous strain on a finite resource (the design team) in industries where there are many diverse designs sold in relatively low volume. o ERA advised that it would be feasible to bring most products within scope from 2012 except for § In vitro diagnostics (IVD) where 2016 was proposed § Industrial test and measurement instruments in 2016-2018 § Active implanted devices such as pacemakers where 2020 was recommended or indefinitely excluded if reliability cannot be assured

The ERA study provided an input to the RoHS review which, at the time of writing, is still on-going. Any change in scope with regard to categories 8 and 9 will only happen with a revision of the directive itself. The EC intends to table a new RoHS draft by around November 2008. It is unlikely that categories 8 and 9 will be brought within scope, if that is what they decide to do, until 2012 at the earliest. It is possible even then that they may exclude part or all of these categories due to health and safety fears or the fact that categories 8 and 9 represent only 1%, or thereabouts, of all electrical equipment put on the market, and that most Producers are going compliant anyway. To that extent RoHS has pretty much done its job already. Either way, both categories would remain within the WEEE Directive and would need to be efficiently, and safely recycled at end of life.

Typical products that would fall with categories 8 and 9: Category 8: Radiotherapy equipment, cardiology, pulmonary ventilators, nuclear medicine, laboratory equipment for in-vitro diagnosis, analysers, freezers, fertilisation tests and other appliances for detecting, preventing, monitoring, treating, alleviating illness, injury or disability. Category 9: Smoke detectors, heating regulators, thermostats, measuring, weighing or adjusting appliances for household or as laboratory equipment and other monitoring and control instruments used in industrial installations such as in control panels. Obviously such equipment would need to be totally reliable and these two categories were originally excluded because of concerns over the use of lead-free solders. Today there is more confidence in the solder and it is felt that this can no longer be a reason for medical devices and monitoring and control instruments to remain outside the scope of the RoHS directive.

Thanks to Chris Robertson at ERA www.era.co.uk/rfa http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=oj:l:2006:396:0001:0849:en:pdf