TABLE OF CONTENTS

Part I . Operation of REACH................................................................................... 3

1..... General Issues..................................................................................................... 3

1.1. Scope and application.......................................................................................... 3

1.2. Definitions......................................................................................................... 17

2..... Registration....................................................................................................... 23

3..... Data sharing and avoidance of unnecessary testing................ 33

3.1. Data sharing...................................................................................................... 33

3.2. Avoidance of unnecessary testing....................................................................... 37

4..... Information in the supply chain............................................................. 46

5..... Downstream users.......................................................................................... 54

6..... Evaluation.......................................................................................................... 60

7..... Authorisation................................................................................................... 67

8..... Restrictions........................................................................................................ 76

9..... ECHA......................................................................................................................... 82

9.1. Process, internal structure and operations........................................................... 82

9.2. Committees....................................................................................................... 88

9.3. Fees and charges............................................................................................... 93

10... Competent Authorities................................................................................. 97

11... Enforcement.................................................................................................... 103

12... Information..................................................................................................... 111

Part II . Achieving REACH objectives............................................................. 116

1..... Human Health and Environment........................................................... 116

1.1. Background and Introduction........................................................................... 116

1.2. Registration..................................................................................................... 118

1.3. Requirements concerning information in the supply chain................................... 120

1.4. Authorisation and restrictions........................................................................... 122

1.5. Conclusions..................................................................................................... 124

2..... Single Market, Competitiveness and Innovation......................... 127

2.1. Background..................................................................................................... 127

2.2. Single market................................................................................................... 128

2.3. Competitiveness.............................................................................................. 131

2.4. Innovation....................................................................................................... 138

2.5. Perspective of SMEs....................................................................................... 144

2.6. Summary and conclusions................................................................................ 145

Part III . CLP Enforcement Activities........................................................... 148

Part I. Operation of REACH 1. General Issues 1.1. Scope and application

Article 1(1) of REACH sets out that the aim of the Regulation is to ensure a high level of protection of human health and the environment, including the promotion of alternative methods for assessment of hazards of substances, as well as the free circulation of substances on the internal market while enhancing competitiveness and innovation. The legal basis for REACH is Article 114 TFEU (Article 95 of the former EC Treaty) relating to the establishment and the functioning of the internal market.

As set out in Article 1(2), REACH applies to substances and mixtures. This Article states further that REACH provisions apply to “the manufacture, placing on the market or use of such substances on their own, in mixtures or in articles and to the placing on the market of mixtures.”

Article 138(6) sets out that: “By 1 June 2012 the Commission shall carry out a review to assess whether or not to amend the scope of this Regulation to avoid overlaps with other relevant Community provisions.” Article 138(6) further states that “On the basis of that review, the Commission may, if appropriate, present a legislative proposal.”

During this review, in the analysis of the scope, the Commission services focused on practical issues where potential overlaps with other relevant EU legislation may appear. In fulfilling this task, different pieces of EU legislation were considered that may be related to REACH provisions. A number of REACH provisions affect the scope of REACH and its Titles, in particular Articles 2, 14, 15, 56, 58, 60, 61, 62 and 67. Annexes I, II, XIV and XVII are also important in the context of discussions on scope especially as they have points of contact with other pieces of legislation. Overlaps, generally, were understood as situations where two pieces of EU legislation regulate the same situation which may lead to instances of legal uncertainty or where legal requirements lead to unnecessary burdens on dutyholders (e.g. imposing the same or similar regulatory requirements twice or imposing conflicting requirements on the same actors pursuant to two different pieces of legislation). The purpose of Article 138(6) should thus be understood as aiming at avoiding these negative overlaps and ensuring more efficient interactions between pieces of legislation at the EU level.

Incidentally, comparing the scope of other pieces of EU legislation with the REACH scope also permits to identify certain synergies that can serve as inspiration for further work of the Commission and stakeholders.

For the purpose of this review, 155 EU legal acts regulating chemicals, products, environmental protection, workers’ protection and food safety have been analysed[1].

The instances of overlaps or potential overlaps between REACH and other EU legislation identified in the review pertain to REACH registration, information in the supply chain, authorisation or restrictions. Two instances of regulatory gaps identified by the review are also outlined in this section. Some examples of pieces of EU legislation concerned by synergies are listed at the end of this Title.

Potential overlaps or overlaps with registration and information in the supply chain

– Safeners and synergists of plant protection products: a potential overlap regarding safeners and synergists of plant protection products was identified, which – like active substances - are subject to Commission approval under the new Plant Protection Products Regulation (PPPR)[2] and for which a review programme will be established by 14 December 2014, but which are not regarded as registered for the purposes of REACH, as they are not mentioned in Article 15(1) REACH. Similar data requirements as those related to active substances should be defined for safeners and synergists in the PPPR implementing legislation. Since the requisite implementing legislation under the PPPR has not yet been adopted, the degree of potential overlap is difficult to assess at this moment in time.

– Co-formulants in biocidal products: a potential overlap regarding co-formulants in biocidal products was identified. Article 15(2) only regards active substances included in the Annexes of the Biocidal Products Directive (BPD)[3] as being registered but not their co-formulants. As a consequence, these have to be registered under REACH. Annex VI of the BPD requires a risk assessment, equivalent the one carried out for active substances, for co-formulants which are substances of concern present in the biocidal product. Therefore the assessment of co-formulants which are substances of concern under both REACH and the BPD may result in a potential overlap. Duty-holders may have to perform a similar risk assessment twice. It must be noted that the BPD has just been replaced by a new Regulation[4]. Similarly to the BPD, Annex VI point 5 of the Biocidal Products Regulation requires a risk assessment for substances of concern. However, the relevant provision sets out that information submitted in the framework of REACH should be taken into account where appropriate. The potential overlap concerning co-formulants thus appears to be sufficiently addressed in the BPR.

– Pyrotechnic articles: The Commission services concluded that certain pyrotechnic articles, considered as mixtures under REACH, might be subject to a double regulatory burden, at least as far as communication of the information in the supply chain is concerned. In such a case both obligations under REACH and under the Pyrotechnic Articles Directive[5] would apply at the same time. According to the current ECHA guidance on requirements for substances in articles, a majority of pyrotechnic articles should be regarded as packaged mixtures, whereas they are regarded as articles by the technical experts in the responsible CEN Technical Committee (TC 212) and also by some competent authorities of the Member States. The Commission services will investigate whether this issue requires specific action, including, in particular in the Guidance on requirements for substances in articles.

– Medical devices[6]: Article 2(6)(c) of REACH exempts medical devices which are mixtures, in the finished state and intended for the final user and which are invasive or used in direct physical contact with the human body, from the provisions of Title IV (Information in the Supply Chain), as long as the same level of information provision and protection is ensured for any substances or mixtures classified as dangerous as under Directive 1999/45/EC[7]. The Commission services take the view that the Directives governing medical devices provide such a level of information provision and protection. The exemption however does not apply to medical devices in the form of articles (such as active implantable medical devices governed by Directive 90/385/EEC), nor does it apply to in vitro medical diagnostics governed by Directive 98/79/EC (as these are not used in direct contact with the human body), even though the latter Directive expressly provides for labelling in line with Directives 67/548/EEC[8] and 1999/45/EC. The scope of the exemption therefore appears very limited. Such articles or mixtures, not being subject to the exemption, would thus be potentially subject to an overlap in terms of information requirement.

Furthermore, the use of a substance in a medical device, and its risks to the safety of patients and medical professionals, is assessed within the context of the Directives on medical devices and the subsequent harmonised standards. Articles 60(2) and 62(6) of REACH recognise this prior assessment in exempting SVHCs used in medical devices from the human health risk assessment in the authorisation process. However, during the REACH registration process, substances used in medical devices are subject to chemical safety assessment for all intended uses. This constitutes a potential overlap as a risk assessment would have to be performed both under REACH and the medical devices legislation.

Under the REACH risk assessment, safe use has to be demonstrated through an exposure assessment, whilst in the Directives on medical devices an exposure assessment is performed and the identified risks then weighed against the benefits. There is thus in addition a potential contradiction in that a substance used in a medical device may not be considered as controlled under Article 14(6) of REACH and Annex I but the risks of the use of the substance may still be accepted under the medical devices legislation.

An overlap was identified for those “Class III” medical devices incorporating, as an integral part, a substance which, if used separately, can be considered to be a medicinal product and which is liable to act on the human body with action ancillary to that of the devices. Such Class III medical devices are assessed and authorised in accordance with Directive 93/42/EEC[9], but the quality, safety and usefulness of the substance must be verified by analogy with the methods specified in Annex I to Directive 2001/83/EC[10], which covers human health risks and requires an environmental risk assessment where applicable. The substances concerned do not benefit from the exemption of Article 2(5)(a) of REACH, as Article 1(5)(c) of Directive 93/42/EEC excludes medicinal products covered by Directive 2001/83/EC[11] from its scope, although the assessment they undergo is comparable to that under Directive 2001/83/EC. There is a potential overlap in that the substances used in these medical devices will be subject to REACH Titles II, V, VI and VII provisions as well as an assessment equivalent to the one set out in the medicinal products directive.

– Workplace legislation: There is certain level of confusion between derived no-effect levels (DNELs) under REACH and various occupational exposure limits (OELs) developed under other EU legislation (Chemical Agents Directive[12] or Carcinogens and Mutagens Directive[13]) or national workers protection legislation and how these two potentially different values should be reflected down the supply chain in the SDS to be used by the employer. Because two sets of values have to be derived under the pieces of legislation, there is a potential overlap.

As far as registrant's chemical safety assessment is concerned, guidance on deriving DNELs in cases when the EU or the national OEL are available is provided in the ECHA Guidance on information requirements and the chemical safety assessment (Chapter R 8).

The Commission services are of the view that OELs and DNELs (for both the same duration and the same route of exposure) may co-exist, and in some circumstances may apply simultaneously to some work activities. In certain cases, where the guidance allows the registrant to use OEL instead of deriving DNEL, the problem of two different values would not arise. In other cases, it is the Commission's view that, in principle, the lowest level should be complied with by the employer. The binding OEL needs to be always complied with by the relevant employer. In cases when the DNEL is lower than the OEL, the compliance with DNEL is based on the premise that the registrant could not use OEL instead of deriving DNEL for the same exposure route and duration, as he has obtained new scientific information which indicated that the OEL does not provide the appropriate level of protection.

Annex II to REACH provides for an obligation to list the relevant applicable EU or national OELs in Section 8 of the SDS (exposure controls/personal protection. Therefore the Commission services consider that more guidance on the relationship between the DNEL and different OELs in the ECHA Guidance on the compilation of SDS would be helpful for dutyholders to fulfil properly their obligation to compile a SDS to avoid confusion between the two systems. The SDS itself could contain some explanation how those two values should be considered by the downstream user as an employer.

– The harmonised classification under the CLP Regulation[14]: Although it has been reported to the Commission that the process of harmonised classification under Title V of the CLP Regulation and the REACH process of identification of substances for the candidate list under Article 59 constitutes an overlap with regard to substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR) under CLP, the Commission services do not concur with that view. The objectives of those two procedures are different, same as the legal implications. The harmonised classification and labelling of the substance under CLP is a different risk management measure comparing to the REACH authorisation. Whereas one of the objectives of CLP is to establish a list of substances with their harmonised classifications and labelling elements at EU level, the candidate list is the first step in the authorisation process under REACH. The purpose of establishing a candidate list is, according to Article 59, the eventual inclusion of substances in Annex XIV, i.e. identifying substances to be subjected to the authorisation requirement. This is why before considering the inclusion of a substance in the candidate list, an assessment of the best risk management option under REACH is performed (see [Title 7]) and no automatic link is assumed between the classification of a substance as a CMR and its inclusion in the candidate list. There is also a substantial difference in the procedure. Under Article 37 CLP, it is the RAC, composed of members with scientific and technical expertise, assessing in-depth (within 18 months of receipt of the proposal) the proposal for harmonised classification and labelling of a substance. In the process of identification of substances for the candidate list under Article 59 REACH, the Committee that may become involved is the MSC, whose composition and role differs from RAC. The assessment under this process is expected to be lighter, under shorter deadlines, and the work already done under the CLP Regulation is already taken into account, as the Annex XV dossier may be limited, if appropriate, to a reference to an entry in Part 3 of Annex VI of the CLP.

– End-of-waste criteria versus recovered substances: Concerns have been reported to the Commission regarding the potential overlap stemming from the fact that recovered substances are subject to REACH registration, unless covered by an exemption. Pursuant to Article 6 of the Waste Framework Directive[15], in order for a certain specified waste to cease to be waste, it has to fulfil the end-of-waste criteria developed either at EU level or at Member State level. Some perceive a potential overlap in risk assessment in that the derivation of end-of-waste criteria already assesses human health and environmental impact of the material (risk assessment carried out as part of the REACH registration for a recovered substance would amount to an overlap, as the same material would have already been subject to a risk assessment at the waste stage.) The Commission services, however, would like to stress that the assessment for the end-of-waste criteria under Article 6 of the Waste Framework Directive is of a different nature as it is carried out by the Member States authorities and it encompasses different elements. The environment and health impact assessment of the material is considered in determining end-of-waste criteria to the extent whether the material in question merits application of the waste legislation. It is assumed that risks from the product of the recovery will be covered by another appropriate legislation. The Commission services would thus conclude that this does not amount to an overlap and does not jeopardise the policy objectives of the two legislations.

– Cosmetics and animal testing: The fact that Article 18 of the Cosmetics Regulation[16] bans animal testing for finished products and ingredients or combination of ingredients and bans placing on the market of cosmetic products containing ingredients or combinations of ingredients tested on animals has been reported to the Commission as an issue of a potential overlap with REACH. Article 2(4)(b) REACH sets out that REACH applies without prejudice to the cosmetics legislation as regards testing involving vertebrate animals within the scope of that legislation. The Commission services continue reflecting on how this issue should be best addressed. It is important to note, in this respect, that REACH envisages the vertebrate animal testing only as a last resort.

Overlaps in restrictions

A number of pieces of EU sector specific legislation provide for restrictions of certain substances or groups or categories of substances. It has been reported that it would be useful to have a publicly available database that would serve as an inventory of all restrictions laid down in EU legislation for particular individual substances. The Commission services do not consider, in general, as an overlap the situation where the same substance is restricted by different pieces of EU legislation provided different uses are restricted by different pieces of legislation. However, the overlap may arise when the same use is restricted in two different pieces of legislation.

Some double restrictions of the same use have been identified which are not entirely consistent.

– PCB/PCT Directive[17]: The PCB/PCT Directive does not provide restrictions, but rather complements REACH restrictions with the rules on the disposal and decontamination of polychlorinated biphenyls and polychlorinated terphenyls. One minor overlap has been identified. The PCB/PCT Directive by allowing a use of PCBs in transformer equipment if the mixture does not contain more than 0.005%[18] seems to be in contravention to the absolute restriction of the use of substances or in mixtures of entries 24, 25 and 26 in Annex XVII to REACH which do not provide such a threshold.

It has been also reported that there may be an inconsistency with respect to the PCB/PCT Directive allowing transformers in which the fluids contain less than 0.05% PCBs to remain in use[19], and the restrictions for the use of entries 1, 24, 25 and 26 of Annex XVII. The Commission services are of the view that this is not an inconsistency, as most of the transformers would be considered as articles under REACH and therefore not subject to the restriction of use as a substance or in mixtures in those entries.

– Toys Safety Directive[20]: The Toys Safety Directive makes it clear in recital (21) and in Annex III that REACH restrictions, when they exist for the use in toys, also apply. However, the Commission services recognise the difficulty for stakeholders to get a clear picture of the regulatory framework and the need to better communicate on it to ensure compliance. The following REACH restrictions are specifically addressed to toys:

· Entries 51 and 52 of Annex XVII to REACH prohibit the use of several phthalates in toys in concentrations greater than 0.1% by weight of the plasticised material, and prohibit the placing on the market of toys containing these phthalates. The Toys Safety Directive does not address phthalates in toys specifically; however, some of the phthalates concerned are classified as toxic to reproduction category 1B and CMRs, in general, cannot be used in toys, components of toys or parts of toys, subject to derogations (Annex II section III to the Toys Safety Directive). The two instruments thus set out a ban with different conditions of applications. The differences in criteria and applicable limits may lead to uncertainty for operators concerned as to their obligations. The Commission services are of the view that the more stringent restriction applies.

· Entry 43 of Annex XVII to REACH prohibits the use of azodyes in, inter alia, textile or leather toys which may come into direct and prolonged contact with the human body, if these azodyes may release certain aromatic amines above 30 mg/kg (0.003% by weight) in the articles or their dyed parts. The placing on the market of non-conforming toys is prohibited. The Toys Safety Directive does not address azodyes. Operators must therefore be aware of relevant restrictions in REACH.

· Entry 5 of Annex XVII to REACH prohibits the use of benzene in toys or parts of toys where its concentration in the free state is greater than 5 mg/kg (0.0005%) of the weight of the toy or part of toy. The placing on the market of non-compliant toys is prohibited. The Toys Safety Directive governs benzene as well: since benzene is classified as a carcinogen category 1A, it cannot be used in toys, components of toys or parts of toys, subject to derogations (Annex II section III to the Toys Safety Directive). The two instruments thus set out a ban with different conditions of applications. The differences in criteria and applicable limits may lead to uncertainty for operators concerned as to their obligations. The Commission services are of the view that the more stringent restriction applies.

The following general REACH restrictions are also relevant for toys:

· Entry 27 of Annex XVII to REACH prohibits the use of nickel in articles (including toys) intended to come into direct and prolonged contact with the skin, if the rate of nickel release from the parts coming into such contact is greater than 0.5 μg/cm²/week. The placing on the market of non-compliant articles is prohibited. The Toys Safety Directive governs nickel as well: since nickel is classified as a carcinogen category 2, it cannot be used in toys, components of toys or parts of toys, subject to derogations (Annex II section III to the Toys Safety Directive); at the same time, and without prejudice to the ban and derogations, specified nickel migration limits from toys or components of toys cannot be exceeded. The differences in criteria and applicable limits may lead to uncertainty for operators concerned as to their obligations.

· Entry 23 of Annex XVII to REACH prohibits the use of cadmium in articles (including toys) produced from plastic material and prohibits the placing on the market of such articles if the concentration of cadmium is equal to or greater than 0.01% by weight of the plastic material. Painted articles (including toys) cannot be placed on the market if the concentration of cadmium is equal to or greater than 0.1% by weight of the paint on the painted article. The Toys Safety Directive governs cadmium as well: specified cadmium migration limits from toys or components of toys cannot be exceeded. The differences in criteria and applicable limits (especially concentration limits versus migration limits) may lead to uncertainty for operators concerned as to their obligations.

· RoHS Directive[21]: Entry 23 of Annex XVII to REACH prohibits the use of cadmium in cadmium plating metallic articles or components for a certain number of applications but permits it for electrical contacts in any sector of use, where that is necessary to ensure the reliability required of the apparatus on which they are installed. The RoHS Directive prohibits the placing on the market of electrical and electronic equipment that contain more than 0.01% of cadmium by weight in homogenous materials. However, Annex III of RoHS provides for an exemption from this restriction when cadmium and its compounds is used in electrical contacts. This exemption from restriction is thus broader than REACH as it does not set out a condition of reliability of the apparatus on which these electrical contacts are installed in order to be triggered. The differences in the conditions of application of the two exemptions may lead to uncertainty for operators concerned as to their obligations.

Potential overlaps related to future restrictions:

In the context of consideration of preparations of future restrictions under REACH, the Guidance on the preparation of Annex XV dossiers states that a restriction under REACH may be an appropriate measure in cases where the proper implementation and enforcement of risk management measures under other REACH processes (notably registration) or under other legislation is not possible to achieve[22]. Other risk management options (RMOs) using other sector specific EU legislation should be explored in order to address the identified unacceptable risk in the most appropriate way. It is important to note that if a Member State or ECHA identifies, in the context of the preparation of the Annex XV dossier, that a measure under other EU legislation is more appropriate way of addressing the risk than a REACH restriction, this should be documented in the Annex XV dossier. In some cases, action under other EU legislation may be considered as a necessary complementary measure to a proposed REACH restriction. These findings could then be used by the competent authorities and the Commission to determine if action under other EU legislation is appropriate. The Commission services recognize that it is important to avoid any possible future overlaps or inconsistencies with restrictions laid down in EU sector specific legislation.

Potential overlaps with REACH authorisation

The Commission services recognise that there is risk of potential overlap once the substance is included in the REACH authorisation list (Annex XIV) and the exemptions for specific uses from the restrictions in different pieces of EU legislation, such as the RoHS Directive[23], the End of Life Vehicles Directive[24] and the Packaging Directive[25]. For uses of a substance which is restricted under sectoral legislation and at the same time subject to REACH authorisation, there is a concern that operators would need to go through two separate and independent procedures in order to be able to continue to use the substance, i.e. one under REACH authorisation, and the other for the exemption to apply under the sectoral legislation. Even if the operator already successfully applied to the Commission for a time-limited exemption for a use under the relevant sectoral legislation, there is no guarantee that the authorisation under REACH would be eventually granted by the Commission for the same use. The provisions in Article 58(2) of REACH allow to exempt uses or categories of uses from authorisation provided that there is specific EU legislation imposing minimum requirements relating to the protection of human health or the environment that ensures proper control of the risks. There is only a limited experience with the use of the Article 58(2) exemption. Three of the current 14 substances in Annex XIV have exemptions from uses based on this provision and in relation to the EU medicinal products legislation. It nonetheless needs to be reviewed how these criteria are currently applied and to what extent they can be used for the exemption of uses covered by exemptions in specific sectoral legislation.

Moreover, the Commission would need to consider how to best use Article 58(2) in order to avoid potential overlaps in other cases, e.g. where the EU workplace legislation sets a binding OEL that applies to a specific use.

The Commission services will explore on a case by case to what extent the Article 58(2) exemption from authorisation may be used in order to exempt from the authorisation requirement the uses that have been already specifically considered in the context of another EU legislation. More generally, the Commission already explores in the risk management options procedure whether it is appropriate to target by Annex XIV substances that are already restricted in many other pieces of EU legislation.

Potential gaps

Potential gaps were also identified in the process of the review. They are outlined below.

– Animal testing: A potential gap was identified regarding the Animal Testing Directive[26]. This Directive defines live non-human vertebrate animals falling under its scope as including earlier forms of development such as ‘independently feeding larval forms’ and ‘foetal forms of mammals as from the last third of their normal development’. Data sharing is obligatory under REACH for data generated from the testing of vertebrate animals, but REACH does not specify that vertebrate animals include larval and foetal forms. It is therefore unclear whether earlier forms of development of vertebrate animals are provided the same level of protection under REACH as under the Animal Testing Directive. The Commission services would recommend construing the term ‘vertebrate animal’ under REACH in the light of Directive 2010/63/EU so as to include larval and foetal forms.

– Use of cephalopods in animal testing: Another potential gap was identified in that the Animal Testing Directive, unlike REACH, covers live cephalopods. Data–sharing would not be compulsory under REACH if the data is generated through test on non vertebrate animals which includes cephalopods. The Commission services will investigate the possibility to subject cephalopods to the same regime as vertebrates.

Synergies in the use of data:

Potential synergies have been identified that relate to information requirements imposed in the context of REACH and those stemming from regulatory requirements from sector specific legislation. Data collected by dutyholders pursuant to one piece of EU legislation could be useful in the context of REACH and vice-versa. Some examples are listed below in bullet points, this list being not exhaustive:

– Quality of Petrol Directive[27]: metallic fuel additives are, in principle, substances subject to REACH registration, the information generated by the registrant for the CSA (depending on annual volumes) can support the Commission’s risk assessment on fuel additives under the Quality of Petrol Directive.

– Textile Names Regulation[28]: Article 25 of this Regulation requests the Commission to examine possible hazards to human health in relation to allergic reactions and chemicals in textile products. To this end, the Commission is carrying out a scientific study to evaluate whether there is a link between allergic reactions and chemicals used in textile products and propose risk management measures, if appropriate. The findings of this study would support the REACH risk identification and management process; among others, such risk management measures may include labelling to indicate the presence of potentially allergenic chemicals. In order to identify which substances could cause allergic reactions and are used in textiles products, the study will make use of the information produced under REACH for the registration, classification and use of substances.

– Paints Directive[29]: this Directive aims to limit the total content of VOCs in certain paints and varnishes and vehicle refinishing products in order to prevent or reduce air pollution resulting from the contribution of VOCs to the formation of tropospheric ozone. These products are however also mixtures under REACH. The solvents and other substances making up these mixtures are subject to REACH registration which means that chemical safety assessments will have to be carried out for these substances. Information available under REACH may thus be useful for the Commission in order to assess whether further measures to address VOC emissions are needed, while the information collected under the Paints Directive can inform exposure assessment under REACH CSA.

– POPs Regulation[30]: REACH registration requirements could help to identify POP substances that could be candidates for nomination as POPs under the Stockholm Convention.[31] Substances listed in the Annexes to the Convention will subsequently be added to the POPs Regulation.

– ELV[32]; WEEE[33], Batteries[34] and RoHS[35] Directives: The process of identifying additional substances of concern for management under the End of Life Vehicle, Waste Electrical and Electronic Equipment, Batteries and Restriction of Hazardous Substances Directives should benefit from the information generated by REACH.

– Water Framework Directive[36]: Data generated through the implementation of the Water Framework Directive and other water-related directives (monitoring, EQS) can be used in carrying out REACH substance evaluations or when considering possible inclusion of a substance on the candidate list or restriction of a substance. Conversely, data from REACH registration dossiers and substance evaluations can be used when implementing the Water Framework Directive.

– Industrial Emissions Directive[37]: Information on the substance under the registration and authorisation procedures under REACH may be used to support the development of BAT reference documents developed under the Industrial Emissions Directive. The CSA comprises the complete life-cycle of the substance and therefore includes the manufacture and use of these substances in industrial installations covered by this Directive and measures to avoid and control emissions.

– Construction Products Regulation:[38] basic requirements for construction works are defined in Annex I to this Regulation to be the basis for EU standardisation. Accordingly, harmonised standards to be adopted or updated by CEN should reflect basic requirements for health and the environment. Such harmonised standards will not address chemical safety as such, but will provide test methods allowing manufacturers to show compliance with relevant chemicals legislation (e.g. REACH restrictions or the Water Framework Directive). Information provided in accordance with Articles 31 or 33 REACH respectively may allow compliance to be shown and thus obviate the need for testing according to harmonised standards; this is a synergy between REACH and the Construction Products Regulation.

For the Commission, it will be particularly important to take into account REACH-generated data, and DNELs in particular, in developing EU lowest concentration of interest (LCI) values[39] in the context of the Commission’s EU-LCI harmonised framework for construction products.

Recommendations

1.1. All efforts should be made to minimise or avoid potential overlaps through adoption or amendment of implementing legislation of REACH or of other EU sector specific legislation, where possible

1.2. Whenever the change of the guidance may address overlaps identified ECHA should consider to carry out the necessary changes

1.3. ECHA should develop a database listing existing restrictions in the EU legislation on a substance base

1.2. Definitions

The REACH definitions are a mix of well established notions and some new concepts. Although few of them have been subject to in-depth discussions by stakeholders and Member States it is important to clearly distinguish between issues related to the implementation of those definitions (which can be addressed via guidance documents) and issues related to the definitions themselves.

The definitions in REACH set out the information necessary to understand and apply REACH correctly. They provide legal clarity in particular in those cases where a term has several meanings in plain language, but must be understood in only one of them in the context of REACH. This sub-title describes the experience acquired with the functioning of the REACH definitions and highlights those definitions which have been subject to extensive discussions or where the Commission observes potential issues of concern. It is also important to mention that the definitions in Regulation (EC) No 1272/2008 (CLP)[40] have been aligned with the REACH definitions.

The definition of substance (Article 3(1)) is the cornerstone of REACH, as substances are the main subject of REACH provisions. The current definition has been well-established in EU law for about 20 years. REACH took over the definition from the predecessor chemicals legislation (Directive 67/548/EEC[41] as amended by Directive 92/32/EEC[42]). The definition of substance is closely related to the identification of each specific substance. This is a crucial precondition for the correct application of risk management measures under REACH (registration, authorisation, restrictions). The Commission services note that substance identification is relevant, first, for the identification of the substance for regulatory purposes (e.g. authorisation, restrictions) and, second, for the establishment of sameness of the manufactured or imported substance, mainly in the context of registration (in establishing Substance Information Exchange Forums (SIEFs) among the potential registrants of the same substance, joint submission or in the inquiry procedure)[43]. The Commission services observe some practical problems mainly in the latter area. This is, however, in the Commission services' view not a problem of the definition of substance as such. The issue is rather linked to the rules on the identification of the substance set out in Annex VI, Section 2 to REACH and in the Guidance on substance identification[44] and to their application in different contexts of REACH (e.g. registration, authorisation). The Commission services notes ECHA's invitation to consider issuing implementing legislation which would ensure that substances of significantly different composition are not merged into single dossiers[45]. It has to be noted that substance identification has been given already considerable attention since the adoption of REACH and has been dealt with within different guidance documents, frequently asked questions, other ECHA support tools, a number of conferences and meetings with different industry stakeholders. The Commission services, ECHA and stakeholders will continue to explore the need for clarifying the existing framework for substance identification. In the registration area, part of the problem may be addressed by Member State enforcement, in cases where it is evident that the provisions related to substance sameness have not been complied with. In summary, the Commission services consider that the efforts in this area (communications, meetings) should be maintained involving stakeholders, Member States, ECHA and the Commission. Additional clarifications will have a direct and positive impact on all REACH processes (registration, evaluation, authorisation and restrictions).

The definition of mixture (Article 3(2)), apart from containing a circular reference to the same word "mixture" after its alignment to GHS[46] terminology through the amendment by CLP, is equally well-established in EU law and does not appear to raise problems in practice. Mixtures are formed by intentional mixing or blending of at least two different substances and, contrary to substances, are not the result of a chemical reaction.

The definition of article (Article 3(3)) has been subject to many discussions (e.g. on candles, printer cartridges, alcohol testers, glow sticks) addressing borderline cases between substances/mixtures in containers or carrier materials on the one hand, and articles on the other. In order to determine whether or not an object fulfils the definition of an article under REACH, the object’s function and its characteristics need to be assessed. This has been clarified to a large extent through the Guidance for substances in articles[47] and its appendices, also on the basis of industry providing specific examples.

Another interpretation issue with respect to the definition of article arose in the context of provisions of Articles 7 and 33 with respect to the 0.1% threshold for substances of very high concern (SVHC) in articles (see [Title 2]). It has been also clarified that the definition of article does not cover buildings as long as they remain fixed to the land on which they stand.

The definition of manufacturer (Article 3(9)) triggered discussions mainly as far as the concept of toll manufacturing (subcontracting) is concerned, as there may be a large variety of different business arrangements in practice. The Guidance on registration[48] gives the basic elements as to the correct interpretation, while leaving some flexibility for industry in specific cases to determine who should be considered the manufacturer of a substance bearing the corresponding REACH obligations. The Commission services consider this solution adequate.

The definition of importer (Article 3(11)), linked with the definition of import (Article 3(10)), is, at times, more difficult to apply to the multitude of practical arrangements existing in practice. The definition of importer is linked to the responsibility for the physical introduction into the customs territory of the EU, which is already considered as placing on the market for the purpose of REACH. The Guidance on registration and other ECHA tools provide help on the correct interpretation of the definition. The Commission services consider this solution adequate.

It is important to bear in mind that the REACH definition of placing on the market (Article 3(12)) is different from that definition in more recent pieces of EU legislation, where placing on the market means only the first making available of a product on the EU market. Therefore, the concept of placing on the market under REACH applies at every step of the supply chain, unless otherwise specified (e.g. in several instances in Annex XVII).

The definition of distributor (Article 3(14)) does not pose problems in the implementation of REACH. However, it should be noted that the reference to a distributor acting for third parties is not interpreted to mean that this definition covers only operators acting on behalf of others. The definition applies to every operator who only stores and places on the market a substance, on its own or in a mixture.

Industry is often contesting the interpretation of the definition of intermediate (Article 3(15)), as clarified through the Guidance on intermediates[49] in April 2010. Differing interpretations of this particular definition may have had an impact on registration dossiers submitted before the first registration deadline. ECHA’s screening of over 400 registration dossiers submitted before the first registration deadline of 2010[50] suggests that some registrants may have unduly benefited from the reduced registration requirements for intermediates set out in Articles 17 and 18. This may, however, mainly be an issue linked to the application of the criteria of the strictly controlled conditions as set out in Articles 17 or 18, and not necessarily an issue of a broader interpretation of the definition. The lack of agreement with industry on the interpretation of the definition may have an impact when assessing whether a use of a specific substance included in Annex XIV is an intermediate use, and therefore not subject to the authorisation requirement. In that regard the Commission services share ECHA's view on the need to further clarify this issue, in particular to clarify with industry which applications can be considered intermediate uses of a substance in accordance with the interpretation set out in the Guidance on intermediates[51].

With respect to the definition of phase-in substance (Article 3(20)), it is useful to note that the criteria in subparagraphs b) and c) may be met only by certain operators, while for other operators the same substance will be considered as non-phase-in substance. The correct identification of the status of the substance has important implications for the registration obligations. In this respect, the Commission services highlight that a second corrigendum was published in the Official Journal concerning the criteria for so-called "no-longer-polymers" in Article 3(20)(c)[52].

It is useful to recall that the definition of use (Article 3(24)) is broad, i.a. including storage or keeping of a substance. This was taken into account, e.g. when Annex XVII to REACH, as taken over from the repealed Directive 76/769/EEC[53], was reviewed and amended by Regulation (EC) No 552/2009[54] and some restrictions were redrafted accordingly.

The definition of exposure scenario in Article 3(37) is repeated in Annex I, Section 0.7 in analogous, but not identical words, which may be considered as superfluous. A similar issue is noted with respect to the definition of use and exposure category (Article 3(38)), which is not consistently used in Annex I. In practice, these issues do not pose any problems.

The scope of the definition of substances which occur in nature (Article 3(39)) was further clarified through the Guidance for Annex V[55], which states, in particular, that living or unprocessed dead organisms, or parts thereof, are not considered substances under REACH. The definition of not chemically modified substance (Article 3(40)) was also further clarified through the Guidance for Annex V.

It is important to note that even if the definition of the term alloy (Article 3(41)) does not specifically mention that an alloy is a mixture rather than a substance, recital (31) as well as Annex I, Section 0.11 and the Guidance on substance identification clarify that alloys are special mixtures. Registration obligations related to substances in alloys are explained in the Guidance on registration.

At this juncture, the term nanomaterial is not defined in REACH, as it is not specifically mentioned in the REACH text. The term has been recently defined in Recommendation 2011/696/EU[56] and should be also understood to apply in the context of REACH practical application as the Recommendation specifically is addressed to Member States, the Union agencies (including ECHA) and economic operators.

The application of REACH, in particular the delimitation of the REACH scope in Article 2, depends also on the scope of some terms defined in other EU legal acts, which are relied on in the interpretation of exemptions from the scope of REACH (e.g. the terms "food", "waste", "by-product", "temporary storage"). Therefore, it is not necessary to define them in REACH.

Conclusions and recommendations

Overall, the definitions in REACH are fit for their purpose and function well. The problems raised by some stakeholders concerning the definition of "substance" are rather linked to the issue of substance identification than to the definition as such.

The main difficulties related to the application of definitions have been observed in relation to the definitions of "article" and "intermediate", as their interpretation is not universally accepted by all stakeholders. The interpretation of the definition of article in connection with the obligations under Articles 7 and 33 is not accepted by some Member States and stakeholders. The interpretation of the definition of intermediate is not entirely shared by industry. The Commission services are prepared to contribute to the discussions with industry on the implementation of this definition.

It is important to note that REACH definitions differ to a certain extent from the aligned reference provisions for the internal market for goods, as set out in Annex I to Decision No 768/2008/EC[57]. These were designed for EU harmonisation legislation for products (e.g. definitions of "placing on the market", "manufacturer", "importer" and "distributor"). Recital (5) of Decision No 768/2008/EC recognises that specificities of sectoral needs may justify other regulatory solutions and explicitly mentions chemicals. The Commission services therefore do not see a need for reviewing whether alignment to those definitions would be appropriate or not at this point in time.

Recommendations:

1.2.1. The definitions in Article 3 have been found to be fit for their purpose and function well. However, if at a later stage REACH will need amending for other reasons:

a. definitions will be reviewed with the view to ensure better coherence between the reference provision in Decision No 768/2008/EC and REACH, if compatible with REACH specific needs and those of Decision No 768/2008/EC. b. consideration should be given to the introduction of the definition of a nanomaterial in line with Recommendation 2011/696/EU

1.2.1. Registrants are encouraged to apply the definition of intermediates, as set out in REACH and further explained in the Guidance on intermediates.

2. Registration

Despite numerous challenges encountered by all actors involved, the first registration deadline should be recognised as a success.

The "R" in REACH stands for Registration, one of the Regulation's core mechanisms. In general, it requires companies to register all substances manufactured or imported in quantities of one tonne or more per year. Registration shifts the burden from the regulator to the industry to demonstrate how substances can be used safely. The registration obligation seeks to address the concerns detailed in the Commission White Paper[58] regarding the lack of information available on 99% of the volume of chemicals on the market in the EU. Failure to register would result in a manufacturer or importer being unable to legally manufacture or/and import their substance.

A registration dossier should demonstrate that the risks through the lifecycle of a substance are controlled. The amount of information required for registration increases along with the volume of the substance manufactured and/or imported. Manufacturers and importers are required to submit a technical dossier for substances registered in quantities of one tonne or more. The technical dossier contains information on the physicochemical, toxicological and ecotoxicological properties, on the uses and on the classification of a substance as well as guidance on safe use. For substances registered at quantities of 10 tonnes or more per year, a chemical safety assessment (CSA) also needs to be conducted and documented in a chemical safety report (CSR) which accompanies the technical dossier.

For substances in specified hazard classes as well as for all substances that meet the criteria for being persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) as set out in Annex XIII to REACH, the CSA includes the development of exposure assessment and risk characterisation for manufacture and all the identified uses of the substance.

REACH provides for the phased registration of substances already on the market in the EU prior to REACH by the following deadlines, where the tonnages indicated are per individual manufacturer/importer (Article 23):

· by 30 November 2010:

– Substances manufactured or imported in quantities of 1 000 tonnes or more per year;

– Substances meeting the criteria for classification as carcinogenic, mutagenic or toxic to reproduction (CMR) category 1 or 2 (under Directive 67/548/EEC) manufactured or imported in quantities of one tonne or more per year;

– Substances meeting the criteria for R50/53 (under Directive 67/548/EEC) manufactured or imported in quantities of 100 tonnes or more per year;

· by 31 May 2013:

– Substances manufactured or imported in quantities of 100 tonnes or more per year; and

· by 31 May 2018:

– Substances manufactured or imported in quantities of one tonne or more per year.

In general, only companies who pre-registered their intention to register a substance at ECHA between 1 June and 1 December 2008 can benefit from these deadlines.

Pre-registration was intended to facilitate the formation of Substance Information Exchange Forums (SIEFs) and thus to increase the efficiency of the registration system, to reduce costs and to avoid duplication of testing, especially testing involving vertebrate animals, to allow downstream users to keep track of whether or not their substances are likely to be registered and also to allow ECHA to anticipate the volumes of registrations to be handled.

Not only due to an unexpectedly high number of pre-registrations but also because registration would involve a large amounts of companies and substances, the Commission followed the process closely during the first years of implementing REACH. Registration contributes to meeting the aims of REACH in a number of ways, directly and indirectly. Through the gathering of data and identification of risk management measures on substances by registrants, better information on risk management can be communicated throughout the supply chain notably on occupational safety, fulfilling one the REACH objectives: to protect human health. Environmental data included in CSRs can also help companies to reduce the environmental impact of their uses of substances, fulfilling another REACH objective: to achieve a high degree of protection of the environment.

REACH introduced a harmonised set of rules for the management of chemicals in the EU. REACH also strives to streamline existing regulatory requirements on chemicals, making the circulation of chemical substances on the internal market easier and seeking to remove national obstacles thereto. Several instruments, e.g. exemptions for research and development or the tiered information requirements, should foster innovation.

Pre-registration

ECHA reports that it received 2.7 million pre-registrations for 146 000 phase-in substances. The number of pre-registrations was 15 times higher than expected[59]. However, as there were no fees for pre-registration it appears likely that many companies pre-registered substances before they were certain whether or not they had registration obligations (i.e. may have adopted a “just in case” approach at this stage), e.g. when their substances were re-imported, recycled, covalently bound during polymer reactions or intentionally released from articles. This approach was supported by guidance and information on the ECHA websites (FAQs). Whatever the reason, the high number of pre-registrations led to a temporary overload of the ECHA IT-systems, and communications with industry on the system usability. Nevertheless, ECHA managed to effectively process pre-registrations by reallocating resources[60].

It was noted that 82% of the pre-registering companies indicated that they were SMEs and 20 000 companies indicated an intention to register before the first deadline (covering approximately 250 000 pre-registrations). However, ECHA reported that only 10% of pre-registrations for the 2010 deadline actually resulted in registrations by that time. The large number of pre-registrations created confusion in the supply chain as to the actual registration intentions and concerns among some downstream users for a discontinuation of a supply of substances. Following the first registration deadline, the Commission has not been presented with any significant evidence in support of these concerns.

Due to the high number of pre-registrations, there were a number of instances where discussions in SIEFs proved very difficult. In some cases, communication within SIEFs broke down altogether. ECHA therefore implemented two additional tools for a smoother functioning: the pre-SIEF, where potential registrants could discuss on the substance identity upfront and find the correct SIEF more easily, and the SIEF Formation Facilitator (SFF), who should initiate the first organisational discussions in the SIEF. Both tools proved to be helpful, although some difficulties were observed, especially with the SFF. The role of the SFF was often abused by certain actors, who had a purely commercial interest in providing their services to other members of the SIEF, or for the purposes of data collection. In some other cases, the SFF did not show signs of activity which meant that other members of the SIEF had to initiate discussions in the SIEF.

ECHA reported that insufficient evidence had been collected about this, making the intervention of Competent Authorities (CAs) impossible in terms of enforcement; The Commission services are nevertheless of the opinion that industry should do its best to eliminate these practices. Within the context of the Directors’ Contact Group (DCG - see below), ECHA also pledged that it would investigate the possibility to improve the REACH-IT pre-SIEF functionality with regards to personal data protection[61]. The Commission services would support further efforts by ECHA to introduce possibilities to screen abuses of REACH-IT for commercial purposes. The Commission services consider that the possibility for a SFF to be replaced by another member of the SIEF could help solving this problem.

The communication in many SIEFs was especially slow in the beginning. A high percentage of members did not respond to any communication at all. The industry organisations reacted to this by establishing a "voluntary code", giving guidance to SIEF members on how and to what extent they needed to get involved in the preparation of a joint submission[62]. This proved to be a helpful tool in supporting an organised and efficient SIEF process.

In order to address i.a. the above challenges, the Commission invited six selected industry organisations and ECHA to become members of the DCG. The DCG monitored progress towards meeting the first registration deadline. It also sought to reduce practical obstacles to SIEF formation and registration of substances and to address foreseeable practical situations not detailed in REACH. The DCG gathered important feedback on the industry’s daily work with REACH.

Registration

By the end of 2011, 27 418 complete registration dossiers had been submitted to ECHA for 3 676 phase-in and 1 670 non-phase-in substances, so in total 5 346 substances.

By June 2011, ECHA checked approximately 400 intermediate registrations and concluded that in 86% of the cases the conditions that allow claiming the provision of reduced information requirements had not been sufficiently demonstrated or justified[63].

The vast majority of registration dossiers were submitted by large companies (87%). Medium-sized companies had a share of 8%, small 4% and micro-enterprises only 1%. In total, 19% of the registrations were submitted by Only Representatives on behalf of non-EU manufacturers. ECHA assessed the evidence provided for reduced registration fees based on claimed SME status from 66 companies and found that 58% had wrongly identified themselves as SMEs[64].

Table 1 below outlines the number of registered substances per year and by type of dossier.

Table 1. Number of submitted dossiers

Completed dossiers || 2008 || 2009 || 2010 || 2011 || Total

Registration of on-site isolated intermediates || 12 || 85 || 1 373 || 2 394 || 3 864

Registration of transported isolated intermediates || 46 || 196 || 3 426 || 546 || 4 214

Full registration dossiers || 10 || 217 || 18 969 || 144 || 19 340

Total registrations || 68 || 498 || 23 768 || 3 084 || 27 418

Source: ECHA, The Operation of REACH and CLP, p. 10, Table 1.

Overall, ECHA evaluates the registration process to date to have been a success, in part thanks to the well-functioning IT-system. For the next deadline, ECHA intends to further streamline the IT processes and to develop additional tools. The work of the DCG showed that the availability of the relevant (parts of the) IT tools in all EU languages may be of importance to ensure access by companies, in particular SMEs, to the tools needed for fulfilling REACH and CLP requirements. In addition, the continuous round-the-clock availability of REACH-IT in the period close to the deadline will give companies additional work time to meet the deadline.

Looking ahead to future registrations, some potential registrants have raised the issue of the capacity of testing laboratories in the run-up to the next phase-in registration deadline[65].

Industry also reported, notably within the context of the DCG, that stability of guidance documents published by ECHA was an important issue. As guidance is heavily relied on for compliance by industry, the Commission services also considers that it should remain stable in the months preceding any registration deadline. In that respect, ECHA introduced a six-month guidance moratorium on guidance documents ahead of the 2010 registration deadline as part of the DCG solutions. ECHA intends to respect such moratorium also for the next deadlines.

An overview of the work of the DCG was published on ECHA’s website[66]. It consists of practical solutions to obstacles to registration encountered by some potential registrants in good faith ahead of the deadline.

Inquiry

ECHA's responsibility in the inquiry process is to bring together previous registrants and new potential registrants of the same substance, to enable most efficient data sharing. To do so, a potential registrant of a non-pre-registered phase-in substance or a non-phase-in substance has to submit an inquiry to ECHA. In 2011 alone ECHA received 1 970 inquiries, and managed to process about 2 100 (reducing the backlog from previous year). With an increasing number of registration dossiers this process is becoming more and more important and it will remain so especially after the last deadline in 2018.

ECHA reported that close to the first registration deadline the number of inquiries related to non-pre-registered phase-in substances suddenly peaked, while the quality of the information on substance identification dropped. This led ECHA to reject many inquiries. ECHA believes that some companies may have been acting under the false impression that a submitted inquiry would remedy the fact that their substances had not been pre-registered in due time[67].

Industry members of the DCG reported that in some cases the inquiry process lasted more than three months, which was considered too long and an obstacle to companies to start the manufacture or import of substances. As a result, ECHA has streamlined its internal processes and further improved the communication with companies about required information, in particular on the substance identity. Inquiries were processed more quickly as a result of the implementation of these changes.

ECHA is responsible for the decision regarding sameness of substances in the inquiry process. In order to fulfil this responsibility ECHA is entitled to request from the inquirer all the information on the identity of the substance as specified in Annex VI, Section 2 to REACH. However, bearing in mind the purpose of the inquiry, all the formal requirements of Annex VI, Section 2 may not always be necessary to establish if the same substance has already been registered. The Commission services recommend that ECHA takes previous registrants' discussions (e.g. in SIEFs) into account when deciding on "sameness" under Article 26. Based on the observations so far, the Commission services invite ECHA to bear this in mind and further monitor, where appropriate and feasible, the efficiency of the inquiry process to avoid long waiting periods for industry upfront.

Substances in articles

The definition of article (Article 3(3)) has given rise an interpretation issue in the context of provisions of Articles 7 and 33 with respect to the 0.1% threshold for SVHC in articles. The Commission considers that the definition implies that objects which at a certain step in their life-cycle meet the definition of article under REACH cease to be individual articles once they are assembled into another article and should be considered as components or parts of an article from that moment. The Commission therefore does not consider that the definition allows parts of a more complex article to be articles for the purpose of Articles 7 and 33. This view is reflected in the Guidance on substances in articles.

Nanomaterials

Nanomaterials are a heterogeneous group of materials, with some traditional high volume commodity materials (e.g. carbon black, synthetic amorphous silica), with newly developed medium volume applications such as paints or sunscreens, and with a wide range of new low volume technical and biomedical applications (e.g. catalysts, batteries, solar panels, tumour therapies). The total annual quantity of nanomaterials on the market at the global level is estimated at around 11 million tonnes, with a market value of roughly 20bn €. Furthermore, products underpinned by nanotechnology are forecast to grow from a volume of 200 bn € in 2009 to 2 trn € in 2015[68]. These applications will be essential for the competitiveness of a wide area of EU products in the global market and can provide basis for further innovation in a wide range of other industries[69]. Currently, the direct employment in nanotechnology is estimated at around 300 000 to 400 000 jobs in the EU.[70] There are also many newly founded SMEs and spin-off companies in this high technology area. Nanotechnology has been identified as a key enabling technology (KET) by the High Level Expert Group (HLG) on Key Enabling Technologies.[71]

For a sustainable use of nanomaterials, their safety needs to be ensured in line with the principles of REACH. This raises the question whether some properties of nanomaterials are linked to hazards for human health and the environment not yet addressed by REACH and whether the traditional risk assessment and management approaches underlying the REACH chemical safety assessments are applicable to nanomaterials. This question is analysed in more detail in the Communication on the Second Regulatory Review on Nanomaterials and the attached Staff Working Paper on Nanomaterial Types and Uses, including Safety Aspects [insert quote].

The Regulatory Review concluded that: “In the light of current knowledge and opinions of the EU Scientific and Advisory Committees and independent risk assessors, nanomaterials are similar to normal chemicals/substances in that some may be toxic and some may not. Possible risks are related to specific nanomaterials and specific uses. Therefore, nanomaterials require a risk assessment, which should be performed on a case-by-case basis, using pertinent information. Current risk assessment methods are applicable, even if work on particular aspects of risk assessment is still required.”

On that basis, the Second Regulatory Review on Nanomaterials concludes that "Overall the Commission remains convinced that REACH sets the best possible framework for the risk management of nanomaterials when they occur as substances or mixtures but more specific requirements for nanomaterials within the framework have proven necessary. The Commission envisages modifications in some of the REACH Annexes and encourages ECHA to further develop guidance for registrations after 2013". Therefore the Commission services consider that the known hazard and exposure patterns of nanomaterials do not require amendments of the basic REACH rules or new legislation with a similar purpose as REACH.

However, while experience with existing registration dossiers shows that the basic REACH chemical assessment framework is applicable and in principle can be used to demonstrate the safe use of nanomaterials there is a need for more clarity in the registration dossiers on how the safe use of nanoforms is ensured. As a first step, ECHA has provided further guidance which is now available to companies. Moreover, based on available information on technical progress, including the REACH Implementation Projects on Nanomaterials and experience with the current registration dossiers, there is a need to assess relevant regulatory options in particular possible amendments of REACH Annexes to ensure clarity on how nanomaterials are addressed and safety demonstrated in registration dossiers. This should take into account in particular:

current knowledge about risks of nanomaterials compared to conventional substances and potential risks due to lack of knowledge, the potential negative effects of unclear regulatory requirements on environment and health, distorting effects on competition between companies resulting from unclear requirements, identified information gaps in registration dossiers and impacts of modified requirements, including on SMEs.

For that reason, the Commission services will carry out an impact assessment to identify the most efficient measures to address those issues.

Review of Registration requirements for substances in 1 – 10 tonnes

The Commission has reviewed the current registration requirements for substances registered in quantities greater than or equal to one tonne and less than 10 tonnes per year per manufacturer or importer (1 to 10 tonne substances). These requirements are being assessed for their likely ability to identify hazardous properties of relevance to the protection of human health and the environment bearing in mind the impact on the innovation and competitiveness of the EU market. This assessment includes consideration of the identification of human health or environmental classification endpoints sufficient for classification under CLP, especially for CMR endpoints, plus consideration of the identification of potential PBT/vPvB substances.

Options for the adaptation of the current registration requirements have been developed to reflect both increasing and reducing the registration requirements for 1 to 10 tonnes substances. Reduced requirements include considerations about requirements set out for on-site isolated intermediates, and limiting the generation of Annex VII information to that currently available or capable of estimation by alternative methods (including read-across and (Q)SARs). Increased requirements include the addition of selected Annex VIII endpoints of relevance to the identification of C, M, R, P and B properties, and the adoption of the registration requirements for 10 to 100 tonne substances (Annex VIII with and without CSA/CSR).

Conclusion and recommendations

The Commission has reviewed the experience gathered during the pre-registration and first registration phases. These processes were new for all stakeholders involved in REACH. Both industry and authorities (in particular ECHA) invested considerably ahead of the deadline by setting up tools and allocating resources to meet the challenge of the first registration deadline. The first registration deadline involved submission of a high number of dossiers and its relative success reflects good cooperation and goodwill from all the involved parties. Particularly the DCG has given important feedback on the industry’s daily work with REACH.

In conclusion, REACH registration was a success. Registration dossiers were submitted on time, showing that industry complied with the registration obligation and set up the right tools to prepare for registration. ECHA handled the first registration deadline effectively; a high number of registration dossiers were received and the IT system functioned well on ECHA’s side. However, together with industry (e.g. through the DCG) further improvements can be made in preparation of the next registration deadlines.

Recommendations

2.1. Concerning intermediates, as highlighted by ECHA, there is a need for awareness-raising across industry, including a need to encourage updating of registration dossiers.

2.2. The DCG will continue to monitor preparedness of the industry ahead of the next registration deadline. It is recommended that the DCG continues to examine practical issues linked with registration and falling under its mandate.

2.3. Companies should continuously monitor and, where necessary, update their registrations. Equally, any non-compliant dossiers must be brought into compliance.

2.4. Without prejudice to the Commission's legal interpretation of the current legal text on substances in articles in connection to Articles 7 and 33, Member States and stakeholders are invited to provide evidence on what potential environmental or other problems the current REACH provisions on substances in articles.

2.5 Concerning the registration requirements for substances in volumes between 1 to 10 tonnes, there is currently insufficient evidence to justify an alteration of the information requirements. The review has raised a number of issues that call for further investigate in follow up to the Communication on the review of REACH.

3. Data sharing and avoidance of unnecessary testing 3.1. Data sharing

Sharing of data served well both the animal welfare and economic objectives, however, joint registration increased the risks of inappropriate use of substance sameness.

One of the objectives of REACH is to avoid unnecessary testing, especially vertebrate animal testing, whilst generating the necessary information to identify the hazards of substances and manage the resulting risks. In order to avoid animal testing, tests on vertebrate animals shall only be undertaken as a last resort, as per Article 25 of REACH. To meet this objective as well as to increase the efficiency of registration and thus lower costs for enterprises, REACH provides for pre-registered and non-pre-registered substances[72] two similar data sharing mechanisms.

Data must be shared for the same substance in the case of information involving tests on vertebrate animals. Before carrying out tests on vertebrate animals, a potential registrant must make sure that information is not already available from a previous registrant. This is done in a Substance Information Exchange Forum (SIEF) for pre-registered substances or through the inquiry process for non-pre-registered substances. Information not involving tests on vertebrate animals must be shared if requested by a potential registrant of the same substance. The data sharing mechanisms aim to ensure that studies which are already available are shared and that their related costs are agreed and shared amongst potential and previous registrants in a fair, transparent and non-discriminatory way. Importantly, in the case of lacking data, the aim of the sharing mechanism is for potential registrants of the same substance to agree who will undertake the necessary testing to ensure that the test is carried out only once.

In accordance with REACH, ECHA has set up procedures to assist in the resolution of data sharing disputes, as per Article 27(7) for non-pre-registered substances and Article 30(5) for pre-registered substances. They should be initiated as a last resort, i.e. after informal means of resolution have not brought results.

Data sharing plays a crucial role in REACH implementation as it facilitates registration, thereby fulfilling the aims of REACH. The Commission examined several steps of the data sharing process. Registrants of the same substance under REACH ideally have to submit their registration jointly, in line with the so-called "one substance, one registration" (OSOR) principle.

In case of pre-registered substances, the potential registrants first must form a SIEF and then designate a lead registrant. These two activities place a lot of responsibility on the industry as REACH does not prescribe any formal structure for SIEFs. In other words, it is up to the SIEF participants to decide on the sameness of their substance identity and set their internal rules and organisation while respecting EU law (especially competition law). As a third step, SIEF participants must ensure efficient sharing of test data for the purposes of registration.

In case of non-pre-registered substances, the new potential registrant has to contact ECHA with an inquiry providing, i.a., relevant information on the identity of his substance, to enable ECHA to identify previous registrants for the purpose of sharing existing data. The potential registrant may use any study summary or robust study summary which has been submitted in the context of a registration at least 12 years previously without financially compensating the previous registrant(s).

Substance identity and sameness

The determination of sameness of substances based on their individual substance identities following the requirements of Annex VI, Section 2 is central in the establishment of SIEFs for phase-in substances and is applied in the inquiry process for non-pre-registered phase-in and non-phase-in substances. Since one of the main objectives of REACH for registration and the inquiry process is data sharing including the reduction of testing costs and avoidance of unnecessary testing in general and especially on vertebrate animals, it follows that enabling effective data sharing is crucial in the process of determining the sameness of substance identity.

Determination of sameness of the identity of two or more substances based solely on the strict comparison of the set of information gathered pursuant to Annex VI, Section 2 often creates inefficiencies as to the transmission of information on substances. Smooth and efficient data sharing should be the main objective of this exercise. However, each registrant needs to carry out an appropriate scientific and technical exercise to ensure that submitted test data covers the hazards and risks of the substance in all the forms he manufactures, imports and places on the market for all his identified uses.

Determining substance identity and sameness has proven to be a complex task strongly based on case-by-case decisions. The Commission services will, together with ECHA and industry, further work on more refined support to further enhance the identification of substances and the efficiency of data sharing.

Expectations

Expectations ahead of the first registration deadline pertained to how efficiently SIEFs were managed by the industry, which can be measured concretely by the actual reduction of tests and costs that SIEFs achieved and by the number of disputes referred to ECHA. Another important area of expectation was the efficiency of SIEFs in nominating lead registrants and the efficiency of their members in the actual sharing of data. On this last point, particular attention is paid below to the ease of availability and use of letters of access.

Findings

It was recognised by all actors that difficulties arose in the designation of lead registrants and that a certain number of registration dossiers had been either subject to opt-outs or submitted by registrants separately[73]. ECHA noted in particular that there had been difficulties in designating lead registrants because of the high workload involved and a general lack of understanding of the lead registrant’s obligations. The late submission of lead dossiers also caused time pressure on other SIEF registrants. Several solutions outlined by the DCG were developed and implemented by ECHA to address these problems.

The Commission services consider that lead registrant issues need to be further monitored. ECHA indicated that it would focus its 2013 communication campaign on the obligation to submit registration dossiers jointly[74]. In addition, ECHA suggested that lead registrants should be legally obliged to make themselves known to ECHA ahead of registration deadlines[75]. The Commission services would support a mechanism to make lead registrants automatically known to ECHA, through e.g. an IT facility.

After pre-registration, industry was required to form SIEFs and 2 176 lead registrants identified themselves voluntarily to ECHA. ECHA reports[76] that in practice SIEFs appear to have suffered due to the large number of (potential) members, making communication and cooperation complex and resource-intensive and causing delays. This assessment of the operation of SIEFs is shared by the DCG, which also indicates that SIEFs present specific additional challenges for SMEs who have fewer resources and, hence, are more vulnerable to unequal treatment and language barriers[77]. Moreover, SMEs generally cannot invest as much time in REACH-related work as bigger companies, which has in certain cases had an impact on the functioning of SIEFs.

Only a small number of data sharing disputes have been forwarded to ECHA and all were resolved within the deadlines. ECHA believes that the existence of the dispute settling mechanism has encouraged data sharing in the SIEFs. However, ECHA notes that penalising breaches of data sharing obligations is difficult due to the different organisation of enforcement authorities in the Member States. Concerns regarding breaches of competition rules and abuse of the dominant position of some companies within SIEFs and in consortia[78] respectively were reported[79], but could not be substantiated by robust evidence. Often high and opaque costs of letters of access were a particular concern for small firms, which can be mitigated by higher degree of transparency.

It was reported that nearly 90% of all dossiers were submitted jointly, resulting in a total of 2 945 lead dossiers and 19 610 member dossiers (the average ratio of member to lead dossiers was 6.7), leading ECHA to consider the joint submission process to be generally working well.

Opt-outs from joint submission for one or more endpoints were noted in 135 cases across all dossiers. Of all dossiers in the range ≥ 1000 tonnes per year considered, 82 dossiers covering 60 substances included opt-outs. Opt-outs related to a total of 1 437 endpoints; typically two opt-outs were included per dossier. Furthermore, ECHA received either multiple joint submissions (of lead and joint dossiers) or more than one individual (lead) dossier, as well as a joint submission for 250 substances and is investigating the reasons for this. On the basis of these outcomes, the Commission services will be working with ECHA to identify measures to eliminate such duplications.

Conclusions and recommendations

The data sharing provisions fulfilled the expectations with regard to the animal welfare and minimizing costs of data collection for the industry. However, there are particular difficulties in meeting the REACH objectives with regard to demonstrating safe use in cases where results of alternative methods are not sufficiently scientifically argued. The signals of misuse of the position of lead registrants with regard to member applicants – in particular to SMEs are also of particular concern.

The processes so far have shown also that the definition of substance identity and the determination of sameness of substances are some of the most challenging aspects of REACH. The Commission services will keep working on improved practical implementation to further enhance the identification of substances and the efficiency of data sharing.

Recommendations

3.1.1. As to the difficulty in nominating lead registrants in SIEFs, ECHA is invited to consider initiatives to promote early submission of lead dossiers and to raise the awareness of member registrants on the timing of dossier submission.

3.1.2. All activities by ECHA and industry are welcome that help to disseminate "best practices" in SIEFs, including developing IT solutions for improving transparency and communication within SIEFs. Specific support to SMEs is crucial and industry is invited to issue targeted guidance for these businesses. Efforts to make guidance available in more languages are also important for SMEs to be able to fully participate to the data sharing process under REACH. This requires involvement of industry as well as of ECHA.

3.1.3. Industry should work on best practices concerning the transparency of costs for letters of access and the functioning of consortia. As problems of compliance with competition law rules as well as good practice as to the dissemination of confidential business information within SIEFs have also been identified, it is recommended that industry associations work on raising awareness on these rules and principles to the benefit of their members.

3.1.4. ECHA and industry are invited to provide further guidance to companies and authorities for substance identity and the determination of sameness.

3.2. Avoidance of unnecessary testing

Significant amount of data used in the registration exercise did not require additional testing on animals, however, progress achieved in some more elaborate alternative testing methods was slower then expected

Article 25 provides that testing on vertebrate animals to generate information may only be undertaken as a last resort and that it is necessary to take measures to limit the duplication of other tests. It also provides that sharing and joint submission of data shall concern technical data and in particular information related to the intrinsic properties of substances. Article 40 outlines the process for the examination of testing proposals for provision of information specified in Annexes IX and X for a substance.

In addition, REACH implements the principles of replacement, reduction or refinement (3Rs) as set out in Directive 2010/63/EU[80] in the use of testing and test methods involving vertebrate animals laid down in Regulation (EC) No 440/2008[81]. These tests and test methods are used to provide data to address the information requirements for substances manufactured or imported in quantities of one tonne or more as set out in Annexes VII to X of REACH.

Information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI are met. In particular for human toxicity, information shall be generated whenever possible by means other than vertebrate animal tests, through the use of alternative methods.

Annex XI provides general rules for adaptation of the standard testing regime set out in Annexes VII–X where testing may not be scientifically necessary, including the use of existing data, weight of evidence such as the use of newly developed test methods recognised by the Commission or Agency as being equivalent, (Q)SAR, in vitro methods and grouping of substances and read-across approach There are also specific provisions for adapting information requirements as set out in Annexes VII-X.

Expectations

The provisions on mandatory data sharing of test data generated on vertebrate animals leading to joint submission of information were expected to make the biggest impact on the avoidance of unnecessary animal testing. Further impact was expected from the use of Annex XI and the submission of testing proposals prior to conducting new test on vertebrate animals.

The use of existing data was expected to provide the most instant impact on the avoidance of unnecessary testing. The major question in relation to existing data is its quality and subsequently its applicability to address information requirements.

It was expected that the use of weight of evidence, in vitro methods and (Q)SAR would need to be developed and improved, and therefore would not make up a high percentage of the alternative methods approaches at this point in time[82]. It was also expected that there would be a need to educate and further develop guidance for registrants and regulators to support the use and preparation of justifications for such approaches and also to promote regulatory acceptance.

Findings

90% of registration dossiers were submitted jointly. This confirms the success of the data sharing and joint submission schemes.

Of the 14 875 dossiers for phase-in substances registered by end of February 2011 in amounts of 1 000 tonnes or more per year, there were only 19 opt-outs concerning endpoints that would have required animal testing. Endpoint study records show that for substances in volumes of 100 tonnes or more, registrants used data generated prior to the introduction of REACH as their main source of data[83]. The second most used source of information was the application of read-across, especially for endpoints that would otherwise require longer-term animal studies. This indicates that the use of the remaining alternative methods (see figure below) to address endpoints is only a developing area and that mainly existing data is used to fulfil information requirements.

Figure 1. Data Sources for Registration Dossiers[84]

Other approaches have been flagged by Registrants as "other information" but this has not been specified in the ECHA report.

In total, 574 testing proposals were received covering 1 175 tests, of which 711 related to in vivo vertebrate animal studies. The operation of the Member State Committee dealing with testing proposals was successful. ECHA noted that a main issue is information quality and that the quality of justifications for not conducting tests (including animal tests) may be insufficiently robust in some registration dossiers. Furthermore, ECHA indicates that a reduced number of testing proposals were received due to the (inappropriate) use of alternative approaches. ECHA also reports that 107 higher tier animal tests seem to have been conducted without prior submission of a testing proposal[85].

In 27 public consultations on testing proposals conducted by ECHA as part of its dossier evaluation activities, no information was obtained from third parties that could be used to fulfil the respective data requirements[86].

The percentage of endpoints that were filled with information from experimental studies (ES), testing proposals (TP) or by use of alternative methods (AM) is provided in Table 2. The column “no data” (ND) applies when information is not required (e.g. because no positive test results triggered the need to conduct further tests).

In summary, registrants have extensively used Annex XI of REACH to waive testing.

Table 2. Share of information types used to fulfil obligations for the different endpoints

Endpoint || % ES[87] || % TP || % AM || % ND

Acute Toxicity || 85 || - || 15 || -

Skin Irritation || 78 || - || 22 || -

Eye Irritation || 75 || - || 25 || -

Skin Sensitisation || 63 || - || 37 || -

Repeated Dose Toxicity || 67 || 7 || 26 || -

Genetic Toxicity In Vitro || 77 || - || 23 || -

Genetic Toxicity In Vivo || 41 || - || 32 || 26

Toxicity To Reproduction || 42 || 10 || 48 || -

Developmental Toxicity || 47 || 10 || 43 || -

Bioaccumulation Fish || 15 || - || 85[88] || -

Toxicity to Fish || 75 || - || 25 || -

Long-term Toxicity to Fish || 16 || - || 82[89] || -

Long-term Toxicity to birds || 7 || - || 92[90] || -

Long-term Toxicity to Mammals || 1.8 || - || 7 || 91

Toxicity to Other Terrestrial Organisms || 4 || - || 4 || 92

Source: The Use of Alternatives to Testing on Animals for the REACH Regulation 2011, European Chemicals Agency, Section 3, pp. 45 – 47.

Development and encouragement of alternatives

ECHA is actively supporting the development of alternative methods by contributing to and hosting the OECD QSAR toolbox and by cooperation with the JRC Computational Toxicology Group to promote the use of computer-based prediction methods. The Commission’s Joint Research Centre (JRC) compiles the (Q)SAR models and administers the (Q)SAR Model Reporting Format Inventory to promote the use of alternative methods. The database is available at the JRC website and is free of charge. ECHA also disseminates information from the endpoint summary records in order to help future registrants to source information that can be used to predict the properties of their substances by read-across or (Q)SARs.

In September 2010, ECHA organised a workshop to clarify uncertainty with regard to the use of non-test methods and develop a common understanding on the use of these methods in the regulatory context. ECHA did not provide any quantification of its support of the development of alternative methods[91]. ECHA is however conducting an ongoing programme looking at inter alia the evaluation of alternative test methods and participates in the development of test methods and guidance documents in the context of the OECD.

20 Member States appear to have made contributions from public funds to EU and/or OECD work on the development and validation of alternative test methods with 17 Competent Authorities (CAs) providing quantification, as set out in Table 3[92]. Overall however, due to inconsistencies between information provided by different CAs, it was not possible to establish a robust estimate of the overall funding patterns for 3R research from the Member States reports discussed in [Title 10].

Table 3. Member State funding for national R&D of alternative testing methodologies86

Level of Funding (Euros per year) || Member state

0 to 10 000 || CY, LI, LV, PL, SI and IS

10 001 to 100 000 || BE and CZ

100 001 to 1 000 000 || BG, DK, ES, FR, NL, SE, UK and NO

More than 1 000 000 || DE

Reflecting its strong commitment to alternative methods to animal testing, the Commission made available funding of about € 330 million in the years 2007 to 2011. Research activities account for the biggest part of the total budget with around € 290 million spent on projects through the 6th and 7th Framework Programmes (FP6/FP7) and the LIFE+ Programme. These funds always needed to be complemented by own resources of the funded entities and, in addition, triggered the spending of further € 25 million from industry through a public-private partnership initiative.

Table 4. Overview of projects on alternative methods/approaches funded by the Framework Programmes (FP6/FP7)

Name || Total awarded grant [million €] || Period

2004 || 2005 || 2006 || 2007 || 2008 || 2009 || 2010 || 2011 || 2012 || 2013 || 2014 || 2015

FP6

Predictomics || 2.3 || || || || || || || || || || || ||

CONAM || 0.15 || || || || || || || || || || || ||

NOMIRACLE || 10 || || || || || || || || || || || ||

TOXDROP || 1.6 || || || || || || || || || || || ||

ReProTect || 9.1 || || || || || || || || || || || ||

ACuteTox || 9.0 || || || || || || || || || || || ||

MODELKEY || 8.4 || || || || || || || || || || || ||

Sens-it-iv || 11.0 || || || || || || || || || || || ||

EXERA || 2.2 || || || || || || || || || || || ||

CAESAR || 1.5 || || || || || || || || || || || ||

VITROCELLOMICS || 2.9 || || || || || || || || || || || ||

MEMTRANS || 1.9 || || || || || || || || || || || ||

EUPRIM-NET || 4.8 || || || || || || || || || || || ||

carcinoGENOMICS || 10.4 || || || || || || || || || || || ||

NANOSH || 2.4 || || || || || || || || || || || ||

DIPNA || 2.8 || || || || || || || || || || || ||

NanoInteract || 3.3 || || || || || || || || || || || ||

Cellnanotox || 2.6 || || || || || || || || || || || ||

SCARLET || 0.11 || || || || || || || || || || || ||

InViToPharma || 0.58 || || || || || || || || || || || ||

INVITROHEARTEART || 2.7 || || || || || || || || || || || ||

LINTOP || 2.9 || || || || || || || || || || || ||

ForInViTox || 0.29 || || || || || || || || || || || ||

ARTEMIS || 2.0 || || || || || || || || || || || ||

COMICS || 2.2 || || || || || || || || || || || ||

OSIRIS || 10.0 || || || || || || || || || || || ||

FP7

START-UP || 0.32 || || || || || || || || || || || ||

CONTAMED || 3.5 || || || || || || || || || || || ||

REEF || 2.9 || || || || || || || || || || || ||

NANOMMUNE * || 3.4 || || || || || || || || || || || ||

NanoTEST * || 3.0 || || || || || || || || || || || ||

OpenTox || 3.0 || || || || || || || || || || || ||

DEER || 3.5 || || || || || || || || || || || ||

NEURONANO * || 2.5 || || || || || || || || || || || ||

NANORETOX * || 3.2 || || || || || || || || || || || ||

ESNATS || 11.9 || || || || || || || || || || || ||

PREDICT-IV || 11.3 || || || || || || || || || || || ||

NANODEVICE * || 9.5 || || || || || || || || || || || ||

ENFIRO || 3.2 || || || || || || || || || || || ||

ENNSATOX * || 2.8 || || || || || || || || || || || ||

ENPRA * || 3.7 || || || || || || || || || || || ||

INLIVETOX * || 2.4 || || || || || || || || || || || ||

NEPHH || 2.5 || || || || || || || || || || || ||

HINAMOX * || 2.3 || || || || || || || || || || || ||

CADASTER || 2.7 || || || || || || || || || || || ||

RISKCYCLE || 1.0 || || || || || || || || || || || ||

SYSTEQ || 2.7 || || || || || || || || || || || ||

EUROECOTOX || 1.0 || || || || || || || || || || || ||

ACROPOLIS || 3.0 || || || || || || || || || || || ||

NANOHOUSE * || 2.4 || || || || || || || || || || || ||

AXLR8 || 0.56 || || || || || || || || || || || ||

CHEMSCREEN || 3.5 || || || || || || || || || || || ||

SCR&Tox ** || 4.7 || || || || || || || || || || || ||

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