Review of the scope of REACH and other relevant EU legislation according to Article 138(6) REACH: description of gaps and overlaps

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1 1 December 2010 DISCLAIMER: This document is a Cefic contribution to the present day to the REACH scope review consultation launched by the Commission and commissioned to the consultancy Milieu. It has been elaborated by Cefic s Legal department in collaboration with some of Cefic s company and federation members. Please note that Cefic s contribution is neither an exhaustive list nor a common position representing the views of the whole chemical industry. Review of the scope of REACH and other relevant EU legislation according to Article 138(6) REACH: description of gaps and overlaps Introduction The European Commission has launched a public consultation on the review of the scope of the REACH Regulation (Regulation 1907/2006), in the framework of Article 138(6) requiring it to assess the need for an amendment by 1 June Stakeholders were invited to provide information on their experience regarding possible overlaps or gaps between the REACH Regulation and other EU provisions, in terms of exemptions, definitions, risk assessment or risk management methodology, authorisation or restriction regimes or other issues. Cefic and its members identified 21 legislations, including proposals for legislations. Please find our contribution here below. General remarks The development of REACH from the White Paper on a Strategy for a future Chemicals Policy (COM (2001)88) onwards makes clear that REACH is foreseen to precede related legislations, existing and especially new ones, unless it is explicitly stated in the vertical legislation that this should not be the case. Existing legislation has to be measured against the scope of REACH and new legislation specific to some uses or situations of chemicals should from now on refer to REACH as the reference legislation for chemicals in Europe. REACH should therefore cover some more aspects to remove certain legislations (e.g. RoHS) and identified overlaps. However, it is appropriate that certain uses have regulatory requirements specific to the sector (e.g. biocides, plant protection, pharmaceuticals, food additives.) but there should be consistency between these regulations. 1

2 Identified legislations by Cefic, in a chronological order (those in brackets are very recent legislations or even proposals but which change the current system considerably) 1. Directive 75/324: aerosol dispensers (and Directive 2008/47) REACH and the Aerosol Dispensers Directive (ADD) both require that all chemicals are used in aerosol in a way that does not adversely affect human health. ADD provisions are fully compatible with REACH and these provisions must be maintained because the majority of aerosol products (e.g. cosmetic aerosols) are not covered by REACH from a consumer health point of view. 2. Directive 76/768: cosmetic products (and Regulation 1223/2009) Overlap: other REACH covers substances used in cosmetic products, mainly from the environmental and workers safety point of view. Cosmetic products are exempt from title IV (Communication in the Supply Chain, see art. 2(6) (a)). The 7th amendment to the Cosmetics Directive as taken up in article 18 of the new Cosmetic Regulation introduced a prohibition of placing on the market cosmetic products containing substances tested on animals to meet the requirements of the Cosmetic Regulation and a prohibition to test these substances on animals to meet the requirements of the Cosmetic Regulation whereas for REACH registration animal tests are required. 3. Directive 88/378: safety of toys (and the new Directive 2009/48/EC) Overlap: restriction One reason for replacing the Directive from 1988 with the new Directive was to introduce new safety requirements, thereby ensuring consistency of the framework. One of these requirements concern chemical substances. Recital 21 holds that It is therefore in particular necessary to complete and update the provisions on chemical substances in toys to specify that toys should comply with general chemicals legislation, in particular Regulation (EC) No 1907/2006 (REACH) and Therefore, new restrictions on CMR substances, in accordance with applicable Community legislation on the classification, labelling and packaging of substances and mixtures, and on fragrances in toys should be provided for on account of the special risks that these substances may entail for human health. An overlap can be noticed where these new restrictions on CMR substances are introduced (Annex II point III 4). Certain CMRs may, by way of derogation, only be used if 3 conditions are met, thereof that the substance or mixture is not prohibited for use in consumer articles under REACH (Annex II point III 4 (c) (iii). With this is introduced an additional substitution of certain substances which is contradictory to the authorisation system of REACH. Overlap: substance specific Another overlap is the way in which phthalates are treated: it goes beyond REACH insofar as it restricts not only DEHP, but also plasticisers such as DINP which received a clean bill of health by an EU risk assessment. REACH should reflect the most up to date evidence (i.e. REACH dossiers should over-ride former restrictions based on a precautionary approach arising from lack of data). The new project from the SCHER committee on CMR substances in toys is up and running and as the title suggests there is the danger of having restrictions based on hazard alone which would not take into account real exposure or the DN(M)EL of an individual substance. Using individual limits for 2

3 individual substances should be a requirement for toys, where currently as much attention is placed on compliance with CEN standards (e.g. EN71) as on the regulations themselves 4. Directive 89/106: construction products (and Regulation (EC) No 1882/2003) The Construction Products Directive (CPD) is currently under revision, the Commission has recently adopted its proposal for a Construction Products Regulation (CPR), to replace the CPD. On 13 September 2010 the Council adopted a first reading position on the CPR. From this proposition we can observe potential overlaps with REACH: Overlap: Information and communication requirements Art. 31, 32, 33, 34 REACH (Title IV: Information in the supply chain) overlaps with Recital 24 of the Council s first reading position on the CPR: The declaration of performance may usefully include information on the content of hazardous substances in order to improve the possibilities for sustainable construction and to facilitate the development of environmentally-friendly products and the Annex I (3) Hygiene, Health and the environment of the CPR. The proposal to require manufacturers to declare their product that contains a dangerous substance would go beyond REACH in terms of providing information in the supply chain. The compromise amendment, adopted by the European Parliament s Committee on Internal Market and Consumer Protection (IMCO) on 22 November, by referring to Art 31 (Material Safety Data Sheet, MSDS) and to Article 33, REACH mixes the obligation to declare substances of very high concern (SVHC), (perfectly acceptable as such, since this provision exists in REACH) with the obligation to provide customers with a MSDS for hazardous materials, forgetting that the latter applies to substances and mixtures, not to articles (=products). REACH information is not suitable for professional users of construction products (GAP of REACH). As a consequence companies have to adapt the REACH information to the needs of workers and consumers. Overlap: Definition of dangerous substances No definition of dangerous substance is provided in the legal text of Directive 89/106. However, dangerous substances in construction products are regulated at national level (both the content and the emissions of dangerous substances) creating in practice barriers to trade within the EU. What is more, the indicative list of dangerous substances regulated at national level represents an overlap with REACH Annex XVII (restrictions) Overlap: Substance specific issues Substance-related requirements for construction products at national level are at present not consistent with REACH. Relevant information in REACH exposure scenarios shall be used for the assessment of results of tests according to harmonised CPD methods. For example DNELs, inhalation, long-term, consumer shall be used for indoor-air-related assessments under the CPD. Either the substance-related requirements for construction products shall be defined on European level in harmony with the REACH regulation or the Commission should force the member states to set or to change the national requirements so that they are consistent with the REACH regulation. Different limit values for the same substances and the same use scenarios create unnecessary uncertainty regarding the legality of construction products. 3

4 Overlap: Risk assessment/risk management issues The CPD does not introduce itself a risk assessment methodology. The relevant information in the REACH exposure scenarios shall be used for the assessment of construction products. For example, DNELs, inhalation long-term consumer information shall be used for indoor air assessments of construction products. Overlap: Other The assessment of the safe use of dangerous substances in construction products at substance level (REACH compliance) and additionally at product level (CPD/CPR compliance) represents a duplication of efforts for the construction manufacturers, without added value for the environment, the health of the workers or the consumers. Overlap: Individual substances- Phthalates For the alignment with the Construction Products Regulation, there should be use of the findings in the REACH dossiers of individual substances. For example, there is a lot of activity and discussion on chemicals emitted into indoor air. There was a SCHER committee some years ago that concluded that phthalates were not seen as a priority for further work on chemicals in indoor air. This is backed up by REACH dossiers since levels of emission are either zero or very low, but this has not prevented large scale requests for declaration of the presence of (any) phthalate in a construction product. Some means of using such results in the development of any new requirements for Essential Requirement 3 of the CPR would be very useful. We understand from the UK authorities that the REACH candidate list is seen as over-riding other legislation (a finding of safe use under Risk Assessments was concluded to be over-ruled by the appearance of DEHP on the candidate list). It would be interesting to see if this can be reversed by incorporating a clause stating that if a use had been shown to be authorised under REACH then it could not be further restricted in the CPR. 5. Directive 91/414 concerning the placing of plant protection products on the market (and Regulation 1107/2009) Overlap: Specific Authorisation or Restriction regimes In reviewing/revising REACH and in particular Article 15.1, Regulation 1107/2009/EC relative to the placing of plant protection products on the market should be taken into account. It should for example reflect the fact that safeners and synergists will be in the scope of that regulation. Coformulants should be removed from Article 15.1 for the following reasons: Regulation 1107/2009 will apply when REACH is revised Synergists and safeners will be treated by that regulation in a similar manner as active substances Co-formulants are by nature general chemicals with multiple applications in various industry sectors. Therefore they should in principle be evaluated under REACH including their uses in plant protection products (Regulation 1107/2009 only contains a 'negative' list of co-formulants). Overlap: substance specific issue: Consideration should also be given to spray adjuvants. These are used in agriculture & horticulture, being mixed with Plant Protection Products to give a spreader/sticker function extending life of the 4

5 PPP actives. Some are also sprayed alone, as antitranspirants (reducing water loss) and/or frost protectants. They are neither active substances nor co-formulants in PPPs and currently are subject to differing national regulations in various EU Member States, but their ingredients are also regulated under REACH. Regulation 1107/2009 announced that revision of the PPP Directive will include new EU regulation of adjuvants (data requirements and registration procedures to be established): if/when these new requirements are planned, double regulation by overlap with REACH must be avoided. 6. Directive 93/42/EEC concerning medical devices Gap: Exemption of Medical Devices from REACH title IV for risk of human health REACH requires the assessment of components of medicinal products (art. 2 (5) (a) and 2(6) ((a) and (c)) although they are partly already assessed under the Directive concerning medical devices. It is a gap that not all the medical devices are exempt from risk evaluation on human health as it is the case for cosmetic products. We therefore propose to apply the exemption from Title IV provided in Art. 2.6c to medical devices in the finished state to both, preparations and articles, as well as far as regards to possible risks to human health. Overlap: Specific Authorisation or Restriction regimes: Divergent Assessment of Risk to Human Health Under REACH, every substance classified as dangerous and produced above 10 ton / per year, requires a CSA (Chemical Safety Assessment) supported with exposure scenarios to demonstrate the safe use of the substance. When it comes to the use of substances in a medical device, that use has been assessed on its risks within the legal context of the Medical Devices Directives and the subsequent harmonized standards. Of course the latter risks refer to the safety of patients and medical professional. This has been recognized by the Commission and resulted in a de facto exemption for a risk assessment of substances in medical devices from authorization as described in article 60.2 and 62.6 of the REACH Regulation, based on human health factors only. However, there is still an overlap between REACH in the Registration process and the Medical Device Directives when it comes to evaluating the risks to Human Health. Moreover, the risk assessment evaluation in REACH and the Medical Device Directives differs. In the REACH regulation, safe use has to be demonstrated through an exposure assessment, whilst in the Medical Device Directives an exposure assessment is performed and the identified risks are weighed against the benefits. This is based on the fact that risks of medical interventions are a fact of life, whilst no medical intervention can be in some cases worse. The risk basis for REACH is the precautionary principle, which results in a risk avoidance regime. This difference in evaluation of risks may result in different outcomes; under REACH the risks of the use of a substance in a Medical Device can be considered too high, while under the Medical Devices Directives the risks of the use of the substance in a Medical Device are accepted, because of the critical function it performs. Furthermore this risk-benefit analysis is documented in the technical files of medical device manufacturers and monitored by notified bodies designated by competent authorities. 5

6 Overlap: Specific Authorisation or Restriction regimes Article 2.6c) takes into account the fact that all necessary information addressing possible risks to human health of the final user are covered by the essential requirements of the following directives: Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC of 14 June 1993 concerning medical devices or Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices. These directives, however, do not only cover preparations but also all necessary information for the safe use of articles. Overlap: Risk assessment/risk management issues To address this issue, the use of a substance in a device falling under the scope of the Medical Devices Directives should be exempted from the Human Health risk assessment in the Chemical Safety Assessment of the Registration (CSA) and Article 14 of REACH (Chemical safety report and duty to apply and recommend risk reduction measures) should be amended. The Medical Devices Directives are tailored to deal with these risks to patients and the medical professionals and should not be overruled by any other Regulation that does not take into consideration the benefits of a medical device. 7. Directive 98/8 concerning the placing on the market of biocidal products Overlap: exemptions While the REACH regulation has foreseen specific provisions for the active substances used in biocidal products, nothing is mentioned about co-formulants. This means that they are subject to the same obligations under REACH as other substances, leading to double legislation and assessment. Therefore in order to avoid duplication of legislation, Cefic s proposition is that the use of a substance as a co-formulant in a biocidal product is exempted from being assessed in the chemical safety assessment of this substance. 8. Directive 98/24/EC on the protection of the health and safety of workers from the risks related to chemical agents at work and Directive 2004/37 on the protection of workers from the risks related to exposure to carcinogens and mutagens at work Overlap: risk assessment and management measures Art. 2 (4) (a) REACH provides that REACH shall apply without prejudice to Community workplace and environmental legislation, including Directive 89/39 and Directive 98/24/EC. This is supplemented by Art. 125 (2), the free movement clause, which provides that Nothing in this Regulation shall prevent Member States from maintaining or laying down national rules to protect workers, human health and the environment applying in cases where this Regulation does not harmonise the requirements on manufacture, placing on the market or use. Both articles show that worker s protection enjoys a special status under REACH. However, the specialised Directive 98/24 provides for a number of risk assessment and management measures which go further than the respective measures under REACH, for example the obligation for employers to determine and assess the risk of hazardous substances at work (Art. 4). The EU Commission has published a Guidance for employers on controlling risks from chemicals Interface between Chemicals Agents Directive and REACH at the workplace with the following core messages: 6

7 The arrival of REACH should improve worker health and safety by providing better information, by establishing new channels of communication between employers and suppliers and by removing from the market substances of very high concern. Although REACH is a new system, and a new way of thinking, the requirements of CAD as implemented into national legislation continue as before. The arrival of REACH does not mean that employers obligations are duplicated. Where employers are already meeting the requirements of CAD they should, in many cases, have little more to do than review their risk management in the light of new information received as a consequence of REACH, and implement changes where necessary. At the very least, there should be efforts to clarify the differences between DNELs, OELs and national OELs (for instance, DNELs are not meant to be operational values) and Directive 98/24 has to refer to the REACH regulation as regards the Safety Data Sheet. DNEL/DMEL derivation should take into account manufacturing experience, where it exists. 9. Regulation 1980/2000 on a revised Community Eco-label Award Scheme (and Regulation 66/2010 on the EU Ecolabel) Gap: other (choice of substances) EU ecolabels are granted according to three principles: criteria shall be determined on a scientific basis (Article 6(3) of Regulation (EC) No 66/2010), they shall be established after a thorough consultation process which includes among others the views of all interested parties (Article 8 and Annex I of the Regulation) and they should respect a separation of powers between the bodies which set and which apply the criteria for ecolabels and which deal with appeals. The old Ecolabel Regulation (EC) No 1980/2000 stated that the Ecolabel may not be awarded to preparations that are classified in certain hazard categories. This is legally equivalent to preparations containing hazardous substances in concentrations above the threshold that leads to classification of that preparation in said hazard categories. After a recent revision [Regulation (EC) No 66/2010], the EU Ecolabel may not be awarded to goods containing substances or mixtures that are classified as very toxic, toxic, dangerous to the environment, carcinogenic, toxic for reproduction, or mutagenic in accordance with Directive 67/548 or Directive 1999/45. No threshold value was indicated, which creates problems for Competent Bodies when evaluating applications (as the logical consequence is a threshold of zero which is not feasible in reality). A threshold of 0.1% (w/w) corresponding to the REACH concentration threshold for communication duties on Candidate List substances in articles needs to be introduced (see REACH Articles 7.2 and 33). Moreover, draft implementing acts use the wording the product or any *homogeneous+ part of it this is not in line with the ECHA guidance on requirements for substances in articles (page 17). By implementing Risk Management Measures - that are binding under REACH a safe handling of substances is ensured. An additional labelling of products (containing such substances) that would restrict the free circulation of those substances would in this respect be duplicate regulation. 7

8 10. Directive 2002/95 on the use of certain hazardous substances in electrical and electronic equipment (RoHS, and proposal COM(2008)809) Overlaps: restriction, exemption; substance specific The RoHS Directive, currently under recast, is the most striking example of Community legislation where overlaps with REACH should be avoided. The Commission gives two reasons for the revision: the commitment to develop a better regulatory environment and to review the measures provided for in the Directive, among others for the adaptation of the list of restricted substances. Overlapping restriction of substances: Proposal COM(2008)809 introduced in its Art. 4 a restriction procedure which mentions the methodology of REACH but is not aligning the two procedures. Article 4 (7) of the RoHS recast says: When there is an unacceptable risk to human health or the environment, ( ) the list of prohibited substances in Annex IV shall be reviewed using a methodology based on the process set out in Articles 69 to 72 of Regulation (EC) No 1907/2006. The recast process is ongoing but the compromise which has been adopted by the European Parliament and which will probably be the Council s position too has a reinforced link to REACH in so far as Annex XVII of REACH or decisions regarding authorisation requests in the context of its Title VII shall be taken into account (new Art. 6a). However, this alignment only seems to cover the results of a restriction procedure and not the procedure as such (criteria and method). As a consequence, RoHS would still establish a parallel, duplicating system to the procedure already in force under the REACH Regulation. We therefore request a further alignment to REACH. Overlap for granting of exemptions: REACH establishes clear criteria for the attribution of an exemption to the legislation. The exemption process in RoHS (Art.5 of the recast) should be aligned with REACH in terms of the application of the same criteria and should take into consideration the outcomes of the REACH evaluation process. Overlap when assessing substances: the REACH legislation has put in place instruments for the assessment of chemical substances, involving the participation of chemicals specialists. This should be used for RoHS too. The recast proposes to establish a parallel, duplicating system within RoHS, where the development of a substance assessment methodology as well as the assessment of chemical substances is undertaken by a Committee composed of waste experts. The newly inserted Recital 22a of the recast RoHS Directive requests a thorough analysis of the coherence with REACH when reviewing this Directive. This might be the occasion to consider a merger of RoHS and REACH. 11. Regulation 850/2004 on persistent organic pollutants (POPs) Gap: Others These instruments establish strict international regimes for initial lists of POPs (16 in the UNECE Protocol and 12 in the Stockholm Convention). Both instruments also contain provisions for including additional chemicals into these lists. They lay down the following control measures: Prohibition or severe restriction of the production and use of intentionally produced POPs The POP Regulations are not only bans, they can also be used as a risk management instrument exempting uses which are still allowed. 8

9 Restrictions on export and import of the intentionally produced POPs (Stockholm Convention) Provisions on the safe handling of stockpiles (Stockholm Convention) Provisions on the environmentally sound disposal of wastes containing POPs Provisions on the reduction of emissions of unintentionally produced POPs (e.g. dioxins and furans) New substances added to the Stockholm Convention in May 2009 and to the POP Protocol in December Both POP regulations have decided new substances for listing, the Stockholm (9 new) have been included in the EU POP regulation (850) this August. Now that we have REACH dealing with chemicals in EU (i.e. at regional scale), including all substances, uses, etc., all (industrial) chemicals are regulated. The only reason there might be a need for additional Regulation could be for substances that have a potential to impact beyond the regional scale. This means they could have an impact at the global scale, which is typical for POPs. The only global POP Regulation is the UNEP-Stockholm Convention, so that is the appropriate Convention. 12. Directive 2006/12 on waste Gap: substance specific Under REACH, waste as defined in Directive 2006/12 is not considered as a substance and therefore most REACH requirements do not apply to waste (Art.2.2). Nevertheless, suppliers of chemicals must show that risks can be properly managed also in the waste life-cycle stage (Art. 3(37)). Once recovered substances cease to be waste, they are again subject to REACH requirements, with a number of exemptions. A guidance document on the interpretation of the Waste Directive is currently under preparation, which will include end-of-waste criteria. The review should ensure that recycling is not hampered while protecting downstream users and consumers. It would be very useful if an amendment to REACH could state which monomers have been registered so as to give a blanket authorisation for recycling operations that are recovering the polymers of that monomer. At present, officially, all recyclers of PVC should have pre-registered VCM. Dealing in complex chemicals legislation (getting a UUID, signing up to REACH-IT, preregistering, finding CAS/EINECS numbers, finding the C&L status of a substance that they will never handle) is not in the common competence of plastics recyclers. Finding some way of removing the need for an active involvement in administrative side of REACH for plastics recyclers would be especially welcome. 13. Directive 2009/125 on Ecodesign Art. 1 (4) on the scope holds that This Directive and the implementing measures adopted pursuant thereto shall be without prejudice to Community waste management legislation and Community chemicals legislation, including Community legislation on fluorinated greenhouse gases. Apart from this, chemicals are only treated indirectly in Annex I Part I which contains a nonexhaustive list of parameters which have to be used for evaluating the potential for improving the environmental aspects. Paragraph 1.3 (d) reads as follows: (d) use of substances classified as hazardous to health and/or the environment according to Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative 9

10 provisions relating to the classification, packaging and labelling of dangerous substances and taking into account legislation on the marketing and use of specific substances, such as Council Directive 76/769/EEC of 27 July 1976 on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations or Directive 2002/95/EC. Gap: risk management issue REACH does allow for restrictions on the use of hazardous substances as one option of risk management measures. However, while REACH considers the risk, i.e. both hazard and exposure throughout the life-cycle, the eco-design Directive considers hazard properties only. This is an inconsistency. Application of hazard-only-based criteria for eco-design, as laid out in Annex I, part 1, paragraph 1.3 (d), would lead to de-selection of a large number of chemicals. What is more, if the focus of the eco-design Directive shifts from energy and materials efficiency to the restriction of hazardous substances, we would have an eco-design on top of RoHS on top of REACH, thereby compromising the objective of smart regulation. 10