and Restriction of Chemicals, Classification, Labelling and Packaging and Sector Specific European Union Legislations

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1 4 Registration, Evaluation, Authorisation and Restriction of Chemicals, Classification, Labelling and Packaging and Sector Specific European Union Legislations Ales Bartl 4.1 Introduction This paper considers the impact of the European Union (EU) legislation on chemicals and of sector specific legislation incumbent to importers and manufacturers of protective textiles. In particular, it focuses on the immediate consequences of the Regulation on Registration, Evaluation, Authorisation and Restriction of CHemicals (REACH) and Classification, Labelling and Packaging (CLP) Regulations to the industry and on future regulation of nanomaterials at the EU level. It addresses the regulatory situation as in March REACH Regulation The most important legislative acts relevant for importers and manufacturers of chemical substances and articles containing chemical substances in the EU is Regulation 1907/2006, on the REACH. REACH came into force on 1 st June 2007 and is affecting, among others, the choice of materials and/or processes used in industry. The main tools of REACH are: Registration, Authorisation, and Restriction of chemicals substances on their own, in mixtures or in articles. All three tools are relevant for manufacturers and users of chemical substances used in polymeric protective clothing. Registration is applicable to any importer or manufacturer of any chemical substance and, to a limited extent, to manufacturers of articles. As a consequence of authorisation and restriction, substances of a high 61

2 Polymeric Protective Technical Textiles concern (such as flame retardants used in protective clothing) will be phased out for all or for specified uses. We note that according to Article 3 (2) of REACH, EU Member States may allow for exemptions from REACH in specific cases for certain substances, where necessary in the interests of defence (this exemption may include e.g., clothing for ballistic protection). 4.3 REACH Registration According to Title II of REACH related to the registration of chemical substances, no chemical substance can be manufactured or imported in the EU, Iceland, Liechtenstein and Norway, above one ton per year per company, without being first registered with the European Chemicals Agency (ECHA), in accordance with the applicable registration deadline (30 th November 2010, 31 st May 2013 and 31 st May 2018, depending on the volume of substance used annually and the degree of hazard posed by the substance). If substances were not pre-registered by their manufacturers/ importers, the above deadlines do not apply. In such a case, they must be registered instantaneously. Late pre-registrations for market newcomers have to be submitted within six months after the manufacturing or importing above one ton per year and no later than 12 months before the relevant registration deadline. Therefore, the 31 st May 2013 deadline is not available for late pre-registration any longer. Some substances are per se exempt from registration (Annexes IV and V, REACH). Uses in specific industries are also exempt from registration. Registration places a relatively heavy burden on substance manufacturers or importers (downstream users of a manufacturer/importer who has registered are covered by the registration) who are required to submit dossiers detailing the substance, its uses, and relevant health and safety information regarding possible harm to human health or the environment. Substances present in articles (manufactured or imported in quantities above one ton/year/company) must also be registered if they are intended to be released under normal or reasonably foreseeable conditions: Specific registration regime for polymers Because of the potentially extensive number of different polymer substances on the market, and since polymer molecules are generally regarded as representing a low 62

3 Registration, Evaluation, Authorisation and Restriction of Chemicals, Classification, Labelling and Packaging and Sector Specific European Union Legislations concern due to their high molecular weight, this group of substances is currently exempted from registration under REACH (Article 2 (9) of REACH). Polymers may, however, still be subject to authorisation and restriction (see next). Nonetheless, manufacturers or importers of monomers have to register monomers or other substances used as building blocks of the polymer in accordance with the normal registration obligation laid down in Article 6 of REACH, as these molecules are generally recognised as of higher concern than the polymer molecule itself. The manufacturer or importer of a polymer must therefore submit a registration to ECHA for the monomer substance(s) or any other substance(s), that have not already been registered by an actor up the supply chain, if both the following conditions are met: The polymer consists of 2% weight by weight (w/w) or more of such monomer substance(s) or other substance(s) in the form of monomeric units and chemically bound substance(s); and The total quantity of such monomer substance(s) or other substance(s) makes up one ton or more per year (the total quantity in this context is the total quantity of monomer or other substance ending up in the final polymer unbound or chemically bound to the polymer). As regards the definition of polymer, according to Article 3 (5) of REACH: A polymer is a substance consisting of molecules characterised by the sequence of one or more types of monomer unit. Such molecules must be distributed over a range of molecular weights. Differences in the molecular weight are primarily attributable to differences in the number of monomer units. A polymer comprises the following: (a) A simple weight majority of molecules containing at least three monomer units which are covalently bound to at least one other monomer unit or other reactant; and (b) Less than a simple weight majority of molecules of the same molecular weight. In the SPCM Judgment (Case C-558/07), the European Court of Justice clarified that Article 6 (3) of REACH and therefore the requirement for a manufacturer/importer of a polymer to register a monomer substance under certain quantity and concentration conditions only concerned monomers that are in a reacted condition (i.e., integrated into the polymer) to the exclusion of residue monomers. 63

4 Polymeric Protective Technical Textiles 4.4 REACH Authorisation Authorisation is one of the procedures for managing the risks of hazardous substances introduced by REACH. Substances that will be subject to authorisation may not be used in the EU, unless the company using them, an actor up its supply chain or its immediate downstream user has been authorised to do so. This means that eventually these substances will be phased out for all non-essential uses. Furthermore, articles can no longer be produced in the EU if they contain substances subject to authorisation and such authorisation has not been granted for the production of this article. On the other hand, Articles produced outside of the EU incorporating substances subject to authorisation can continue to be used in the EU (unless this substance is further used in the EU). Substances to which authorisation will apply are listed in the Authorisation list included in Annex XIV of REACH ( Annex XIV ). The first 14 substances have recently been added to Annex XIV (e.g., flame retardants - see next) and the procedure for inclusion into Annex XIV of 8 additional substances is ongoing (April/May 2013). After inclusion in Annex XIV, each listed substance is given a specified date after which it may no longer be used without authorisation (the so-called Sunset date ). For example, the Sunset date for the first six substances which were included varies between 42 and 48 months from 21 st February If an application for authorisation of a substance included in Annex XIV is made at least 18 months before the Sunset date, then, unless already rejected, the applicant can continue using the substance after the Sunset date has passed, until a decision on the application is taken (the so-called Latest application date ). Before a substance is included in Annex XIV, two steps must take place: First, the substance must be identified as a substance of very high concern (SVHC) and included in the Candidate List of Substances of Very High Concern for Authorisation ( Candidate List ), which is managed by ECHA [1]. Secondly, the SVHC in the Candidate List is subject to further evaluation and negotiation which may lead to its inclusion in Annex XIV (and, thus, to the authorisation requirement). The following types of substances are eligible to become SVHC: Carcinogenic, mutagenic or toxic for reproduction (CMR) (in Category 1 or 2), or Persistent, bio-accumulative and toxic (PBT), or Very persistent and very bio-accumulative (vpvb), or 64

5 Registration, Evaluation, Authorisation and Restriction of Chemicals, Classification, Labelling and Packaging and Sector Specific European Union Legislations Substances giving rise to an equivalent level of concern to substances meeting the above criteria, such as substances with endocrine disrupting properties or substances where there is scientific evidence of probable serious effects to human health or the environment. Such substances will be identified on a case-by-case basis. EU Member States, ECHA and the European Commission (EC) have the right to trigger the procedure of inclusion of a substance into the Candidate List. Currently (March 2013) there are 138 substances on the Candidate list [1]. Periodically (twice a year), ECHA checks the substances on the Candidate List and identifies and recommends priority substances to be added to Annex XIV. If a substance appears on Annex XIV and the Sunset Date has passed, industry must either substitute the substance with another substance or submit an application for authorisation. Alternatively, companies should check whether their suppliers intend to submit an authorisation application and whether they can benefit from this application (an authorisation is covering all companies down supply chain and one immediate upstream user). Companies should keep in mind that even if they do not use a substance listed in Annex XIV, they may still be affected if the substance is used further up their supply chain. If a company uses goods, which were manufactured by its EU supplier using a substance listed in Annex XIV and if the authorisation has not been granted for that use to the supplier, the company will no longer be able to use these goods. Thus, each company must be aware of its supply chain. An application for authorisation for use of an Annex XIV substance must be submitted to ECHA and will need to include a Chemical Safety Report covering the risks related to the properties that led to identification as an SVHC and must provide an assessment of alternatives. It should also include a substitution plan if the conclusion is that there is a feasible alternative substance, and possibly a socio-economic benefits analysis in case a safety threshold cannot be established. An authorisation may also be submitted jointly. This allows companies to share data and costs and to better identify socio-economic benefits (but triggers competition law issues). As stated above, Annex XIV currently (March 2013) contains 14 substances: 5-Tert-butyl-2,4,6-trinitro-m-xylene (musk xylene) 4,4 -Diaminodiphenylmethane 65

6 Polymeric Protective Technical Textiles Hexabromocyclododecane Bis(2-ethylhexyl) phthalate Benzyl butyl phthalate Dibutyl phthalate Diisobutyl phthalate Diarsenic trioxide Diarsenic pentoxide Lead chromate Lead sulfochromate yellow Lead chromate molybdate sulfate red Tris(2-chloroethyl) phosphate 2,4-Dinitrotoluene Some of these substances can be used also in polymeric protective clothing, e.g., as flame retardants. Some uses of substances listed in Articles 2 and 56 of REACH are automatically exempt from the authorisation requirement (mostly because they are controlled under other more appropriate laws). Finally, each entry in Annex XIV of a substance may be followed by uses or categories of uses, which are exempted from the authorisation requirement. However, except for medical devices, this categorical exemption has not yet been applied. 4.5 REACH Restriction The REACH restrictions regulate the manufacture, placing on the market or use of certain substances if they pose an unacceptable risk to health or environment [2]. Any substance on its own, in a preparation or in an article may be subject to a restriction if it is demonstrated that risks need to be addressed on a Community-wide basis. Substances to which a restriction applies, together with specific restrictions of use are listed in Annex XVII of REACH [3]. Thus, if imported articles with Annex XIV listed substances escape from authorisation, they can be caught by restrictions under Annex XVII. Currently (March 2013) there are 67 restrictions in Annex XIV. 66

7 Registration, Evaluation, Authorisation and Restriction of Chemicals, Classification, Labelling and Packaging and Sector Specific European Union Legislations According to Article 67 (3) of REACH, until 1 st June 2013, a Member State may maintain any existing and more stringent restrictions in relation to Annex XVII on the manufacture, placing on the market or use of a substance, provided that those restrictions have been notified. 4.6 REACH Requirements on Safety Data Sheets Safety data sheets (SDS) have been the standard system for communication of information relating to dangerous substances and preparations under the former EU legislation on dangerous chemical substances. REACH introduced new requirements for SDS in The obligation to provide an SDS to its customers is incumbent to suppliers of the substance, i.e., to manufacturers or importers of the substance. The relevant provisions under the REACH Regulation can be found in Title IV (Information in the Supply chain) and Annex II (Guidance to the Compilation of Safety Data Sheets). Annex II of REACH was itself amended in May 2010 by Regulation 453/2010 [4]. When compiling SDS, it is necessary to provide, among others, the classification of the substance/mixture (see the following paragraph): (i) Products for which an SDS must be provided without prior request. In accordance with Article 31 REACH, an SDS must be provided (even without request) for chemical products if they are: Considered dangerous (i.e., when they meet one or more of the criteria set out in the Dangerous Substances Directive (DSD) or Dangerous Preparations Directive (DPD) see the following paragraph); PBT or vpvb materials; or Are SVHC that are on the Candidate List (see the previous paragraph). (ii) Products for which an SDS must be provided on request. Article 31 (3) of REACH specifies the conditions under which an SDS for mixtures must be supplied on request. In brief, the threshold of concern is typically where the mixture contains: An individual concentration of at least 1% w/w (solids or liquids) or 0.2% v/v (gas) for hazardous substances; 67

8 Polymeric Protective Technical Textiles A concentration of 0.1% of a substance of higher concern including Category 1 sensitisers, CMR, vpvp, PBT and others meeting the definition in Article 59 of REACH; or Where the substance has a defined EU exposure level. (iii) Access to information in the SDS to workers. According to Article 35 of REACH: Workers and their representatives shall be granted access by their employer to the information provided in accordance with Articles 31 and 32 in relation to substances or mixtures that they use or may be exposed to in the course of their work. Companies are obliged to grant workers access to information contained in SDS in relation to any substances, which they use or may be exposed to in the course of their work. (iv) Obligation to update an SDS. Suppliers shall update an SDS without delay if: New information which may affect risk management measures becomes available; If an authorisation has been granted or refused; or If a restriction has been imposed. 4.7 Classification and Labelling of Chemical Substances All manufacturers or importers are required to classify and label substances or mixtures they supply. The classification of a substance or mixture reflects the type and severity of the hazards of that substance or mixture, i.e., its potential to cause harm to human beings or the environment. The EU legislation on classification, labelling, and packaging consists of three acts: (1) The DSD - Directive 67/548/EEC (European Economic Community) [5]; (2) The DPD - Directive 1999/45/EC (European Commission) [6]; and 68

9 Registration, Evaluation, Authorisation and Restriction of Chemicals, Classification, Labelling and Packaging and Sector Specific European Union Legislations (3) The new Regulation on classification, labeling, and packaging of substances and mixtures, Regulation (EC) No1272/2008 (CLP Regulation) [7], which entered into force on 20 th January Under the CLP Regulation, there is a transitional period of time granted to suppliers of chemicals to change from the DSD/DPD classification system to the CLP rules given in Table st December st June 2015 Table 4.1 The transition period applicable to substances Classification/SDS: Suppliers must classify substances according to both the DSD and the CLP. Labeling and packaging (L&P): Suppliers must L&P according to CLP, although by derogation, substances classified, labeled and packaged according to DSD and already placed on the market (e.g., in stock) before 1 st December 2010 are not required to be relabeled and repackaged under CLP until 1 st December st June 2015 onwards Classification/SDS: Suppliers must classify according to CLP. L&P: Suppliers must L&P according to CLP. The timelines for the rules for the classification of mixtures are listed in Table th January st May st June 2015 onwards Table 4.2 The transition period applicable to mixtures Classification/SDS: Suppliers must classify mixtures according to DPD and may also classify according to CLP (in which case they may include CLP classification on the SDS under the other information heading). L&P: DPD rules apply, unless: if suppliers also classify according to CLP, they must L&P according to CLP (not DPD). Classification/SDS: Suppliers must classify according to CLP L&P: Suppliers must L&P according to the CLP, although by derogation, mixtures classified, labeled and packaged according to the DPD and already placed on the market (i.e., in stock) before 1 st June 2015 are not required to be relabeled and repackaged under CLP until 1 st June

10 Polymeric Protective Technical Textiles In the EU, substances are classified (and labelled accordingly) either by: (1) using the harmonised classification that is provided for under EU legislation, or (2) by a process of self-classification Harmonised Classification CLP Regulation requires that if a substance was classified by the competent EU authorities (entry into Annex I of DSD or into Part 3 of Annex VI to the CLP Regulation), standard harmonised Classification and Labelling are used. Over 4000 substances have received a harmonised Classification and Labelling Self-Classification In the absence of harmonised Classification and Labelling or where harmonised Classification and Labelling is available for some endpoints only, a substance or a mixture should be self-classified by the operator according to the rules set out in Article 6 and following of the CLP regulation. This can be done by (1) gathering available information (e.g., from other operators, or test data); (2) examining such data (e.g., for adequacy and reliability; (3) evaluating and reviewing the information; and (4) if the substances meet the criteria, assigning a qualification. 4.8 European Union Regulation of Nanotechnology Nanomaterials are widely used in manufacturing of clothing and garments, e.g., for their anti-bacterial properties. However, due to safety concerns associated with the manufacturing and use of nanomaterials, there are attempts at both the EU and Member States level to regulate nanotechnology [8]. At present, EU regulation of nano-materials is partial, inconsistent and concerns only specific sectors, such as cosmetics, electronic equipment or plastic food contact materials. On 18 th October, 2011, the European Commission ( Commission ) published Recommendation 2011/696 on the definition of nanomaterial ( Recommendation ) [2]. The Recommendation defines nanomaterials as follows: Natural, incidental or manufactured material containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50% or more of the 70

11 Registration, Evaluation, Authorisation and Restriction of Chemicals, Classification, Labelling and Packaging and Sector Specific European Union Legislations particles in the number size distribution, one or more external dimensions are in the size range 1 nm 100 nm. Where: Aggregate: Particle comprising of strongly bound or fused particles. Agglomerate: Collection of weakly bound particles or aggregates where the resulting external surface area is similar to the sum of the surface areas of the individual components. In specific cases and where warranted by concerns for the environment, health, safety or competitiveness the number size distribution threshold of 50% may be replaced by a threshold between 1% and 50%. A material should be considered as falling under the definition in point 2 (i.e., definition of nanomaterials) where the specific surface area by volume of the material is greater than 60 m 2 /cm 3. However, a material which, based on its number size distribution, is a nanomaterial should be considered as complying with the definition in point 2 even if the material has a specific surface area lower than 60 m 2 /cm 3. The use of the new definition is not mandatory. However, it is likely that it will be used in all types of legislation, both at the EU and national levels, with possible deviations for specific regulatory needs. In November 2012, the Joint Research Center of the Commission issued a document Requirements on measurements for the implementation of the European Commission definition of the term nanomaterial [3] which provides an in-depth review of methods available to measure the size of nanoparticles. In addition, the Staff Working Paper on Nanomaterial Types and Uses, including Safety Aspects [4] ( Working Paper on Nanomaterial Types and Uses ) issued in October 2012 by the Commission provides further guidance on the nanomaterial definition (Section 2.5). The Paper also provides a preview on the health and safety aspects and on the types of nanomaterials, including nanosilver (see next). On 5 th February 2013, the Commission adopted the General Report Review of REACH [5]. With respect to nanomaterials, the Report notes that the Commission will make an impact assessment of relevant regulatory options, in particular possible amendments of REACH Annexes, to ensure further clarity on how nanomaterials are addressed and safety is demonstrated in the registration dossiers. If appropriate, the Commission will come forward with a draft implementing act by December

12 Polymeric Protective Technical Textiles Specific regulatory provisions on nano materials are already available at the EU Member States level. For example, France has recently established a mandatory reporting scheme on nano-materials, which requires mandatory information on quantities and uses of nano materials as well as the identity of the professional users. This scheme also contains specific provisions imposing mandatory reporting and risk disclosure requirements on anyone who imports, manufactures or markets nano particle substances on their own or in mixtures or articles with a release potential in France. The reporting system began in 2013 for 2012 data. 4.9 European Union Legal Framework concerning Personal Protective Equipment Protective Claims, Labelling and Presentation The EU General Product Safety Directive 2001/95/EC (GPSD) [9] contains general safety requirements to be met by products, including textiles and garments marketed to consumers (not professional equipment). Amongst other things, the GPSD envisages consideration of foreseeable misuse, labelling and extensive information for consumers as well as the possibility of withdrawal or recall to avoid any product-related hazards. Thus, if a manufacturer of a product claims that the apparel effectively protects the user, the manufacturer should be sure that these claims are correct. Otherwise, there would be a risk that the product would be considered unsafe and defective in which case the manufacturer would be strictly liable for any damages and the product would have to be recalled. Any claim or any other presentation of a product can be also considered as a misleading commercial practice according to Directive 2005/29, Unfair Commercial Practices Directive [10]. Article 6 (1) of the Unfair Commercial Practices Directive defines a misleading commercial practice as a practice which contains false information and is therefore untruthful or in any way, including overall presentation, deceives or is likely to deceive the average consumer, even if the information is factually correct, in relation to one or more of the following elements, and in either case causes or is likely to cause him to take a transactional decision that he would not have taken otherwise. In determining whether advertising is misleading, all features must be taken into account, and in particular, any information concerning the characteristics of goods 72

13 Registration, Evaluation, Authorisation and Restriction of Chemicals, Classification, Labelling and Packaging and Sector Specific European Union Legislations and services, such as their nature, composition, and so on. Whether or not a practice is misleading is for the assessment of the competent authorities of the EU Member States Personal Protective Equipment Directive Directive 89/686/EEC on personal protective equipment [11] is a basic piece of legislation regulating personal protective equipment (PPE) at the EU level. PPE is defined as: any device or appliance designed to be worn or held by an individual for protection against one or more health and safety hazards. However, according to Annex I of the PPE Directive, PPE designed and manufactured specifically for use by the armed forces or in the maintenance of law and order and personal protective equipment for self-defence are excluded from the scope. In order to sell any item of PPE within the EU, it is necessary to be able to demonstrate that it satisfies the requirements of the PPE Directive. Annex II of the PPE Directive provides a summary of the basic health and safety requirements (BHSR) with which products must comply. In many cases harmonised European standards (with what is known as a presumption of conformity) are available in order to show compliance with BHSR Export of Military Technology and Equipment Export of military technology is regulated at the EU level by the Council s Common Position 2008/944/CFSP (The Common Foreign and Security Policy) (Common Position) [12], adopted on 8 th December It includes several new elements, which deepen and widen the scope of application of the former European Union Code of Conduct on Arms Exports (which has been repealed by the Common Position). These elements include the extension of controls to brokering, transit transactions and intangible transfers of technology, as well as the implementation of strengthened procedures in order to harmonise the Member States export policies. In addition, the Council adopted the Common Military List of Equipment which lists equipment which is covered by the Common Position. Protective clothing are covered by this Common Military List (under entry ML7.f.1.) and therefore, the EU exporters of protective clothing for military purposes must comply with the rules set out by the Common Position. 73

14 Polymeric Protective Technical Textiles 4.11 Conclusion The EU will continue to be the key driver for product regulation. In particular, chemical restrictions and phase-outs are expected at increased speed. There is less room for sector and company specific product stewardship efforts. Such efforts are to be concentrated on products/chemicals that are crucial and highly threatened by REACH. Therefore, a prioritisation of efforts is needed. Industry is advised to fully address the present and future compliance challenges now to allow enough time for change of product design, and to start including the new requirements in contracts with other parties in the supply chain. Manufacturers, in particular, should make sure that they are comfortable with the level of risk they are assuming under the terms of any compliance certification provided to customers for future products. References 1. Candidate List of Substances of Very High Concern for Authorisation, ECHA, Helsinki, Finland Restrictions Process, ECHA, Helsinki, Finland REACH, ECHA, Helsinki, Finland. en.asp 4. COMMISSION REGULATION (EU) No 453/2010 of 20 May 2010 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), European Commission, Brussels, Belgium, CONSOLIDATED VERSION of Council Directive 67/548/EEC of 27 June 1967 on the Approximation of Laws, Regulations and Administrative Provisions Relating to the Classification, Packaging and Labelling of Dangerous Substances as Amended Taking Account of Changes up to 1/08/

15 Registration, Evaluation, Authorisation and Restriction of Chemicals, Classification, Labelling and Packaging and Sector Specific European Union Legislations 6. DIRECTIVE 1999/45/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 31 May 1999 Concerning the Approximation of the Laws, Regulations and Administrative Provisions of the Member States Relating to the Classification, Packaging and Labelling of Dangerous Preparations, European Commission, Brussels, Belgium, :0068:en:PDF 7. CLP Legislation, ECHA, Helsinki, Finland Draft Commission Recommendation of [ ] on the Definition of the Term Nanomaterial, European Commission, Brussels, Belgium DIRECTIVE 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on General Product Safety, European Commission, Brussels, Belgium, :EN:PDF 10. DIRECTIVE 2005/29/EC of the European Parliament and of the Council of 11 May 2005 Concerning Unfair Business-to-Consumer Commercial Practices in the Internal Market and Amending Council Directive 84/450/ EEC, Directives 97/7/EC, 98/27/EC and 2002/65/EC of the European Parliament and of the Council and Regulation (EC) No 2006/2004 of the European Parliament and of the Council ( Unfair Commercial Practices Directive ), European Commission, Brussels, Belgium, :EN:PDF 11. Council Directive of 21 st December 1989 on the Approximation of the Laws of the Member States Relating to Personal Protective Equipment (89/686/ EEC), European Commission, Brussels, Belgium, : :EN:PDF 12. Acts Adopted under Title V of the EU Treaty Council Common Position 2008/944/CFSP of 8 December 2008 Defining Common Rules Governing Control of Exports of Military Technology and Equipment, European Commission, Brussels, Belgium, :EN:PDF 75

16 Polymeric Protective Technical Textiles Further Reading 1. Commission Recommendation of 18 th October 2011 on the Definition of Nanomaterial :EN:PDF 2. T. Linsinger, G. Roebben, D. Gilliland, L. Calzolai, F. Rossi, N. Gibson and C. Klein in Requirements on Measurements for the Implementation of the European Commission Definition of the term Nanomaterial, JRS Reference Report, Report No. EUR 25404, EC Joint Research Centre, Geel, Belgium, irmm_nanomaterials%20%28online%29.pdf 3. Types and Uses of Nanomaterials, including Safety Aspects: Accompanying the Communication from the Commission to the European Parliament, the Council and the European Economic and Social Committee on the Second Regulatory Review on Nanomaterials, European Commission, Brussels, Belgium, FIN:EN:PDF 4. General Report on REACH - Accompanying the document: Report from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions in Accordance with Article 117(4) REACH and Article 46(2) CLP, and a Review of Certain Elements of REACH in line with Articles 75(2), 138(3) and 138(6) of REACH, European Commission, Brussels, Belgium, FIN:EN:PDF 76

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