www.element14.com/legislation globallegislation@element14.com REACH Regulations compliance guidance: www.element14.com/legislation REACH Regulation January 2014 Compiled with the support of ERA Technology Ltd. www.era.co.uk 1 www.element14.com/legislation globallegislation@element14.com Guide to compliance with the EU REACH Regulation Background: Introduction REACH, Regulation (EC) 1907/2006, is the most significant piece of legislation to impact manufacturing in the last 25 years. It supersedes 40 existing legal measures as a harmonised system applying to all chemicals manufactured, used or present in products in the European Union (EU). It is thought that it applies to around 30,000 chemicals currently in use in the EU. REACH shifts the onus from regulators to industry to show that the chemicals it uses are safe to use. The EU’s policy is “no data - no market”. REACH stands for Registration, Evaluation, Authorisation (and restriction) of Chemicals which describes its central processes. It has been assumed by many product manufacturers that because this regulation concerns “chemicals” it is of no relevance to the engineering and electrical products sector. This is definitely not the case. All products are made of chemicals and REACH has both direct legal and indirect impacts on this sector. This document briefly explains the REACH regulations and gives guidance on how manufacturers and importers should comply. About this guide This guide is based on the European Chemical Agency (ECHA) official guidance and on the REACH regulation itself. It is split into three sections: background, definitions and obligations. The number of incidents of allergies, asthma, certain types of cancer, and re-productive disorders are on the increase in Europe and chemicals are considered as one possible cause; If REACH succeeds in reducing chemical-related diseases by only 10%, the health benefits are estimated at €50 billion over 30 years; 100,106 chemicals were reported to be on the market in 1981, the only time that chemicals have been listed in the EU; The chemicals sector is the third largest manufacturing industry in the EU, encompassing 31,000 companies and 1.9 million people; Internationally, the EU is the leading chemicals producing area, its €580 billion representing 33% of global sales; For 99% of the most frequently used chemicals (by volume), information on properties, uses and risks is sketchy. There is no data for about 21% of them, and another 65% come with insufficient data. Only 3% have been fully tested; The costs of registration, including the necessary testing, are estimated at €2.3 billion over the 11 years that it will take time to register all the substances covered by REACH. The total costs, including those to downstream users, are estimated at €2.8 billion to €5.2 billion, depending on the extent to which registration costs will increase prices of chemicals and the costs of substituting chemicals that will be withdrawn. Data Source: European Commission Why should I be concerned about REACH? REACH is complex; the regulations were adopted in December 2006 and came into force on 1 st June 2007. The regulation itself runs into several hundred pages and official guidance numbers thousands of pages. Direct legal obligations arise for EU chemical manufacturers, importers of substances into the EU, users and distributors of substances, and also manufacturers and importers of products – what REACH calls “articles”. REACH is accelerating the obsolescence of components and materials and increases the level of information required on the composition of products beyond the mere 6 substances currently covered by the RoHS Directive. DEFINITIONS AND SCOPE What is a substance and what is an article? It is important to differentiate between substances and articles because different obligations apply. For example, it may be necessary to register substances but it is not normally necessary to do this for substances that are constituents of articles. An “article” is the term used by REACH to define items whose form defines their function to a greater degree than their Compiled with the support of ERA Technology Ltd. www.era.co.uk 2 www.element14.com/legislation globallegislation@element14.com composition. To demonstrate this, a straight forward example would be a polystyrene cup. Although made of pure polystyrene, its form (a cup shape) means that it is an article not a substance. Common industry examples of articles are packaging, electronic components, wire, PCBs and finished equipment. By contrast, solder as wire and paste, ingots of alloys, paints and adhesives are examples of preparations or mixtures of substances. There will be cases where it is not clear whether an item is an article (i.e. if the substance is an integral part) or a substance in a container. The ECHA guidance provides detailed criteria by which to judge such cases. Printer cartridges and liquid filled thermometers are classic borderline cases. The former is seen as a substance or mixture of substance (preparation) - ink or toner - in a container (because the substance is dispensed); the latter is seen as an article containing a substance or preparation (the temperature indicating liquid) as an integral part (as it is retained throughout the life of the article). This distinction is important since the REACH obligations on an importer/producer are much more extensive for chemicals / substances than for articles. What does REACH stand for? Registration – the necessity to submit a (technical) dossier on the properties of a substance. Evaluation – of the dossier by the authorities. Authorisation and restriction – on the uses of CHemicals (substance and mixtures of substances). safety data sheets. Downstream User – you use a substance, either on its own or in a preparation, in the course of industrial or professional activities (for example: formulation, dilution, repackaging, spraying, painting). Are metals included by REACH? Yes, metals are chemicals or preparations. Pure metals such as copper are a single substance whereas alloys are mixtures of materials. Brass for example is a mixture of copper and zinc. Are plastics included by REACH? No, polymers are excluded from REACH but any residual monomer and any additives contained within them may need to be registered. Polymer – a polymer is the main constituent of a plastic and consists of many molecules of much simpler chemicals called monomers that are chemically bonded together Monomer – Monomers are the building blocks of polymers. Single monomer molecules are joined to other monomer molecules to build much larger structures that are called polymers. One polymer molecule may contain 100’s or 1000’s of monomer units. OBLIGATIONS FOR ARTICLES Substances in articles Who is affected by REACH? REACH is a regulation that affects manufacturers and importers of substances (chemicals) preparations (mixtures or solutions of substances) and distributors of chemicals. It also affects manufacturers, importers and distributors of articles and anyone who uses chemicals professionally. Substances present in articles, that are not released, dispensed or emitted do not need to be registered. There are two main obligations for substances in articles: Relating to Substances of Very High Concern (SVHC) which are providing information to recipients of articles containing more than 0.1% of an SVHC and Notification if there is more than 1 tonne per annum (tpa). Restrictions; these are listed in Annex XVII. Summary, REACH affects: Manufacturer / Importer – you manufacture or import a substance on its own or in a preparation. Registration will be needed if you make or import 1 tonne or more per year, notification is needed for smaller amounts if the substance has a hazard classification. Producer / Importer or supplier of articles – you produce or import articles, the main obligations relate to SVHCs. Distributor (including retailers) – you store and place on the market a substance, on its own or in a preparation. Duty to pass on SVHC information and SVHCs are hazardous substances that are proposed, reviewed then added to the Candidate List every six months. They may subsequently be added to Annex XIV (substances requiring authorisation for use) or restricted by adding to Annex XVII. Inclusion in Annex XIV only affects the manufacture or use of these substances as chemicals in the EU, it does not affect their import in articles from outside of the EU, unlike Annex XVII restrictions which can restrict substances in articles as well as chemicals. Compiled with the support of ERA Technology Ltd. www.era.co.uk 3 www.element14.com/legislation globallegislation@element14.com There are currently 138 SVHCs and these are listed at the end of this guide. What documentation is required? Documentation is of key importance in fulfilling ones obligations under REACH. This will record the process and criteria used, the judgements made and the basis for these (references, supporting evidence etc.). This is important even if you have no obligations in your view in case this is challenged by competent bodies (enforcement authorities), customers or auditors. REACH requires such information to be kept for at least 10 years. Ways of achieving REACH compliance include incorporating these requirements in your company’s management systems, carrying out assessment in conformance with the work flows provided in the REACH guidance, or following other good practice (e.g. common approaches developed by industry). Information on SVHCs and notification Suppliers of articles are obliged to inform recipients of the presence of SVHCs in articles. The information to be provided is the name of the substance and, if appropriate, instructions for safe use. Suppliers are expected to be proactive and need to find this information if their suppliers do not volunteer it. Requesting this information from suppliers is difficult even though EU based suppliers are obliged to provide it. Priority should be given to educating those involved in production, design and procurement within your organisation and also your supply chain about the requirements of REACH and what is needed of them to ensure compliance. Consider also how you will interact with your supply chain (e.g. what questionnaire should you use) and what data infrastructure you might need (e.g. can you build on what you are already doing for RoHS compliance?). should also consult the candidate list. For articles you will need to ask your suppliers. Estimating the quantities of SVHCs present in your articles will then determine your obligations. Obligation to provide information on the composition of articles The central requirement is to provide sufficient information to ensure safe use. Information must be provided where both the following criteria are met: 1. It is on the candidate list for authorisation (it is a Substance of Very High Concern) 2. The substance is present in the article at > 0.1% by weight of the article as produced in the EU or imported. Note that there is no tonnage criterion, nor are there exemptions due to exclusion of exposure or if the substance is already registered as this is a specific safety issue for the recipient – even if he/she is the only recipient. Where provision of information is required, what the producer, importer or supplier of the article must do depends on the nature of the recipient of the article: Consumers: The article supplier must provide information on request necessary to ensure safe use within 45 days, free of charge. Any other recipient: The article supplier must provide automatically the name of the substance as a minimum plus any other information required to ensure safe use. The kind of things that should be included in the Safe Use Data supplied with information around SVHCs is covered in ECHA guidance. It differentiates between advice to consumers and professional users. For example, consumers might be advised to keep a substance out of the reach of small children, avoid dermal exposure by not wearing certain clothing in direct contact with the skin, or do not use in enclosed spaces. Professionals could be warned against dust inhalation from grinding (ensuring appropriate personal protection is used), and avoid leakage to the environment if using a product outdoors in the rain. Possible SVHCs can be determined through their properties – examining Safety Data Sheets (SDS) you receive should reveal this for substances you use. You A typical safety checklist could be: Exposure controls / Personal protection Handling and storage Disposal consideration Fire fighting measures Transport information. Compiled with the support of ERA Technology Ltd. www.era.co.uk 4 www.element14.com/legislation globallegislation@element14.com Information could be included in safe use, or instructions for use data, and labels on containers might be used in some cases. This obligation applies as soon as a substance has been included in the candidate list for authorisation. This applies to any article supplied after that date. Hence the manufacturer of a product must ensure this information is passed down their distribution chain to recipients whenever articles containing SVHCs are supplied. REACH considers substances to be SVHCs if they are: Carcinogenic, mutagenic or toxic for reproduction (CMR), categories 1 and 2 according to Directive 67/548/EEC or Persistent, liable to bioaccumulate and toxic (PBT), or very persistent and very liable to bioaccumulate (vPvB) according to Annex XIII or Others such as endocrine disruptors, PBTs and vPvBs not meeting Annex XIII criteria for which there is scientific evidence of probable serious effects to human health or the environment. The definition of the percentage limit for SVHCs in articles and for provision of information to customers has proved contentious. The guidance states that the 0.1% concentration applies to the total article and not individual components or material that make up the end product. Several member states lobbied for the tighter restrictions around individual articles but the ECHA has not changed the definition. Obligation to notify the use of an SVHC in articles The obligation to notify the ECHA of a use of substance in an article applies where the following criteria are all met: 1. It is on the “Candidate List” (it is a Substance of Very High Concern); 2. The substance is present in the article at > 0.1% by weight of the total article as produced in the EU or imported; 3. The substance is present in the articles produced or placed on the EU market in quantities > 1 tpa per producer/importer; 4. Exposure to humans or the environment cannot be excluded during normal or reasonably foreseeable conditions of use, including disposal. When is registration of chemicals in articles needed? The only obligation to register is for chemicals that are emitted as an intended function of the article. For example, a perfume used in bars of soap will need to be registered if there is > 1 tpa of the perfume manufactured / sold unless it has already been registered by the perfume manufacturer / importer. Some chemicals in articles are regarded as chemicals such as ink in ink jet cartridges and paint in spray cans (so need registration) whereas some chemicals that are not intended to be released or dispensed such as alcohol in a liquid thermometer are regarded as substances in articles which do not need to be registered. OBLIGATIONS FOR CHEMICALS Who is responsible for registration of chemicals? All manufacturers and importers of substances, preparations and substances have obligations. There is a lower weight limit of 1 tpa per manufacturer / importer per year for registration to apply. This applies mainly to chemicals and mixtures of chemicals but also apply to chemicals that are “intentionally released” from articles during use Manufacturers and importers of substances will need to register substances with the ECHA based in Finland, (http://echa.europa.eu). In order for a substance to be registered, the registrant will need to submit data that is specified by the REACH regulations. It is not possible to register a substance without the required data and unregistered chemicals cannot be manufactured or supplied within the EU beyond certain specified dates. Every manufacturer and importer of a chemical (>1 tpa) will have to register. For example, if there are three manufacturers of one chemical in the EU and each produces more than the 1 tonne limit then all three will have to register it. They can collaborate and share test results to minimise costs. Each of these registrants will also need to state how the chemicals are used based on information supplied by their customers. Note that electrical equipment manufacturers sometimes import unusual chemicals (special paints, adhesives, etc.) from outside of the EU for their production processes. Late pre-registration is possible for substances when these are manufactured or imported in quantities of > 1 tpa. for the first time. For example, if a manufacturer imported only 500 kg in 2012, there were no registration requirements for this substance. However, if they intend Compiled with the support of ERA Technology Ltd. www.era.co.uk 5 www.element14.com/legislation globallegislation@element14.com to import 2 tonnes in 2013, they should use the late preregistration procedure to allow them to import the substance until it is registered. Late pre-registration is permitted until the registration deadlines specified by REACH. Are all chemicals treated in the same way? No, the data required for registration depends on the quantity produced or imported, with more technical data required for 1000 tpa than is required for only 1 tpa. The deadlines for registration of the largest quantities and those of highest concern have already passed, the next deadline is 31st May 2013 for 100 – 1000 tpa, and for 1 – 100 tpa, the deadline is 31st May 2018. The most hazardous chemicals are considered differently and many will be classified as SVHCs. These may also need to be “authorised” before they can be used and authorisation will not be granted if there are safer alternatives or if the substance cannot be safely controlled. SVHC and is listed in Annex XIV, then you will need to apply for authorisation in order to be able to use it. There is no lower weight limit for this requirement. Chemicals are registered for specific uses and these are used to prepare exposure scenarios and you should ensure that you inform the registrant how you use materials, especially if this is unusual. If the registrant does not include your use in an exposure scenario, you will have 12 months to either change the production process, find another supplier who does include your use or you may be able to use the chemical if you submit your own chemical safety report to the ECHA. If you supply chemicals that are classified as being hazardous, you will need to provide a REACHcompliant Safety Data Sheet. Hazard labelling is changing to the new Globally Harmonised System and this will require changes to both labels on containers and to SDS. Some of these obligations are already in force. What impact will REACH have for chemicals and preparations? Implications and obligations will include: Withdrawal of materials from the market – this will happen where the cost of producing the data for registration is higher than expected future profits, but could also occur if a material contains a substance that is an SVHC. The authorisation process is expensive and quite onerous and some suppliers may decide to withdraw products instead. Also, the ECHA may not allow a chemical that poses an unacceptable risk or if they believe that safer alternatives exist. If you import 1 tpa or more of a single chemical or 1 tpa or more of a chemical in a preparation from outside the EU, then this will need to be registered. If you import or manufacture a chemical that is classified as hazardous, in quantities less than 1 tpa, you will need to notify ECHA. This is much simpler than registration. If you import articles into the EU that contain 1 tpa or more of a chemical that is intentionally released (such as a perfume from scented soap), this chemical will need to be registered. If you import articles that contain a SVHC (> 1 tpa of the substance) at a concentration of >0.1% by weight, you need to notify the ECHA. If you import a chemical or preparation to use as a process material (e.g. a special paint or adhesive) and this contains a chemical that is classified as a SVHCS and authorisation in detail Suppliers should now be informing their customers if any of these substances are present in any item at >0.1%.The ECHA will propose more SVHCs in the future and are likely to include a variety of materials that are present in electrical equipment such as lead, cadmium, beryllium and arsenic. They are also likely to include many fairly common chemicals that are widely used in materials such as polyurethane paints and resins, various types of adhesives, sealants, plating chemicals and solvent cleaners. It is recommended that users check manufacturer’s safety data sheets (SDS) as these will list all hazardous ingredients (including their hazard classifications) that are present in substances and preparations, but suppliers do not need to provide SDS for articles. All category 1 or 2 carcinogens, mutagens or reproductive toxins, will eventually be listed as SVHCs as well as certain other types of hazardous substance specified in Article 57 of the REACH regulations. Manufacturers are obliged to make the latest version of the SDS available to downstream users as well as providing safe use data Compiled with the support of ERA Technology Ltd. www.era.co.uk 6 www.element14.com/legislation globallegislation@element14.com where an SVHC is present in an article. When ECHA approves substances for “authorisation of use” they will be added to Annex XIV. Substances in Annex XIV cannot be used after specified (sunset) dates unless they have been authorised. Authorisation will be given only for specific uses, are available only to the applicant (this may include their immediate customers) and will be time limited. Application for authorisation is expected to be very costly and there is no guarantee that they will be granted. Substances requiring authorisation for use It is the EU’s intention that all SVHCs will eventually be added to Annex XIV and this will mean that these chemicals cannot be used after “sunset dates” unless authorisation has been granted for the specific uses. Authorisations are granted to individual applicants. They can be requested on behalf of downstream users of the chemicals but authorisations granted to one supplier cannot be utilised by other suppliers, so all suppliers must apply for and be granted authorisations to continue in business. As a result, substances added to Annex XIV may be withdrawn from the market and at best, only certain specific uses will be permitted. Substances that have been added to Annex XIV so far are listed below. Substance name HBCDD 2,4-Dinitrotoluene Tris(2-chloroethyl) phosphate (TCEP) Diarsenic pentaoxide Diarsenic trioxide Lead sulfochromate yellow (C.I. Pigment Yellow 34) Lead chromate Lead chromate molybdate sulphate red (C.I. Pigment Red 104) Benzyl butyl phthalate Bis(2-ethylhexyl) phthalate (DEHP) Dibutyl phthalate Diisobutyl phthalate 5-tert-butyl-2,4,6-trinitro-mxylene (Musk xylene) 4,4’-diaminodiphenyl methane (MDA) CAS number 3194-55-6 (and others) 121-14-2 115-96-8 Sunset date 21/08/2015 1303-28-2 1327-53-3 1344-37-2 21/05/2015 21/05/2015 21/05/2015 7758-97-6 12656-85-8 21/05/2015 21/05/2015 85-68-7 117-81-7 21/02/2015 21/02/2015 84-74-2 84-69-5 81-15-2 21/02/2015 21/02/2015 21/08/2014 101-77-9 21/08/2014 21/08/2015 21/08/2015 Several more SVHCs have been proposed to be added to Annex XIV and these include several cobalt compounds and most of the water soluble chromate salts that are used for metal passivation coatings and for chromium plating. How are equipment manufacturers located outside the EU affected by REACH? Manufacturers based outside the EU are not affected directly and they cannot register chemicals or obtain authorisation. If they want to do this they can appoint an EU agent (known under REACH as an “Only Representative”). Also, there are no obligations from EU REACH relating to using chemicals outside the EU. If there are SVHCs are present in articles imported into the EU, then the supplier should pass this information to their EU importers. The EU’s authorisation obligation for Annex XIV chemicals does not apply outside the EU so non-EU manufacturers can freely use these substances whereas EU manufacturers can use them only if authorisation has been granted. It has been pointed out that this places EU industry at a competitive disadvantage and relocation of manufacturing is likely as a result. However, there are possible indirect implications for non-EU manufacturers due to REACH. EU importers of their products will ask for information about the chemicals within products. Even if non-EU manufacturers’ products are not sold in the EU, they could be affected by the withdrawal of materials from the market. This is likely to occur as the EU is a large market and producers may stop selling their products around the world if they are forced to withdraw from Europe. Further implications may be new legal restrictions imposed outside the EU. It is possible that other countries and States in the USA and Canada could impose new restrictions on chemicals as REACH produces more comprehensive test data on them. What should I do now? 1. Determine whether any of your products contain SVHCs. If they are, you will need to provide this information to your customers. 2. Find out if any of the chemicals, preparations or materials you use contain a substance likely to be classified as a SVHC? If the answer is yes, then there is a risk that this may be withdrawn from the market without warning. It is best to avoid the use of materials containing SVHCs in new products unless there is no alternative. SVHCs as chemicals may not be used in the EU to make products, even in small quantities, after (sunset) dates that will be specified by ECHA, unless they have been authorised for these uses. Users as well as manufacturers and importers can request authorisation but should seek professional advice first. The next step is to contact your materials suppliers to ask them the following questions: 1. Can your suppliers confirm that REACH will not affect the supply of materials that you currently use? They Compiled with the support of ERA Technology Ltd. www.era.co.uk 7 www.element14.com/legislation globallegislation@element14.com may not be able to confirm this but your question will encourage them to find out what plans their suppliers have and warn you of withdrawals as soon as possible. 2. Do your suppliers require information on how you use their products? If you use chemicals in an unusual way, you should provide details. If you receive an exposure scenario, written by the registrant, that does not include the way you use these chemicals, you will need to either change the way you use it find another supplier or submit your own chemical safety report to the ECHA. Be prepared to answer questions from your customers who will want information on SVHCs present in your products. Legal Obligations There many myths around what information is legally required. Name of any SVHC present in an article Safe Use data to accompany the above 3. Chemical suppliers must provide up-to-date copy of the safety data sheet (SDS); do they have processes to automatically update you if the content changes? SDS should be automatically supplied at time of order 4. Ask your supplier to provide information on any SVHCs that are present in any items, substances or preparations that they supply. Safe use data may be required where an SVHC is present in an article. Provide pre-registration / registration information SDS should be automatically supplied retrospectively when updated Certificates of REACH compliance Current list of SVHCs The current “Candidate List of SVHCs for authorisation” is as follows: Substance CAS No. [4-[[4-anilino-1-naphthyl][4 (dimethylamino)phenyl]methylene]cyclohexa-2,5-dien-1-ylidene] 2580-56-5 dimethylammonium chloride (C.I. Basic Blue 26) [4-[4,4'-bis(dimethylamino) benzhydrylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium chloride (C.I. 548-62-9 Basic Violet 3) [Phthalato(2-)]dioxotrilead 69011-06-9 1,2,3-trichloropropane 96-18-4 1,2-Benzenedicarboxylic acid, di-C6-8-branched alkyl esters, C7-rich (DIHP) 71888-89-6 1,2-Benzenedicarboxylic acid, di-C7-11-branched and linear alkyl esters 68515-42-4 1,2-Benzenedicarboxylic acid, dipentylester, branched and linear 84777-06-0 1,2-Bis(2-methoxyethoxy)ethane (TEGDME; triglyme) 112-49-2 1,2-Dichloroethane; ethylene dichloride 107-06-2 1,2-Diethoxyethane 629-14-1 1,2-dimethoxyethane; ethylene glycol dimethyl ether (EGDME) 110-71-4 1,3,5-Tris(oxiran-2-ylmethyl)-1,3,5-triazinane-2,4,6-trione (TGIC) 2451-62-9 1,3,5-tris[(2S and 2R)-2,3-epoxypropyl]-1,3,5-triazine-2,4,6-(1H,3H,5H)-trione (β-TGIC) 59653-74-6 1-bromopropane (n-propyl bromide) 106-94-5 1-methyl-2-pyrrolidone 872-50-4 2,2'-dichloro-4,4'-methylenedianiline (MOCA) 101-14-4 2,4-dinitrotoluene 121-14-2 2-Ethoxyethanol 110-80-5 2-Ethoxyethyl acetate 111-15-9 2-Methoxyaniline; o-Anisidine 90-04-0 2-methoxyethanol 109-86-4 3-ethyl-2-methyl-2-(3-methylbutyl)-1,3-oxazolidine 143860-04-2 Compiled with the support of ERA Technology Ltd. www.era.co.uk 8 www.element14.com/legislation globallegislation@element14.com 4-(1,1,3,3-tetramethylbutyl)phenol 140-66-9 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated [covering well-defined substances and UVCB substances, - polymers and homologues] 4,4’- Diaminodiphenylmethane (or methylene dianiline) 101-77-9 4,4'-bis(dimethylamino)-4''-(methylamino)trityl alcohol 561-41-1 4,4'-bis(dimethylamino)benzophenone (Michler’s ketone) 90-94-8 4,4'-methylenedi-o-toluidine 838-88-0 4,4'-oxydianiline and its salts 101-80-4 4-Aminoazobenzene 60-09-3 4-methyl-m-phenylenediamine (toluene-2,4-diamine) 95-80-7 4-Nonylphenol, branched and linear [substances with a linear and/or branched alkyl chain with a carbon - number of 9 covalently bound in position 4 to phenol, covering also UVCB- and well-defined substances which include any of the individual isomers or a combination thereof] 5-tert-butyl-2,4,6-trinitro-m-xylene (musk xylene) 81-15-2 6-methoxy-m-toluidine (p-cresidine) 120-71-8 Acetic acid, lead salt, basic 51404-69-4 Acids generated from chromium trioxide and their oligomers. Group containing: Chromic acid, Dichromic 7738-94-5, 13530-68-2 acid, Dichromic acid, Oligomers of chromic acid and dichromic acid Acrylamide 79-06-1 Alkanes, C10-13, chloro (Short Chain Chlorinated Paraffins) 85535-84-8 Aluminosilicate Refractory Ceramic Fibres where: a) Al2O3 and SiO2 are present within the following Extracted from Index no.: concentration ranges: Al2O3: 43.5 – 47 % w/w, and SiO2: 49.5 – 53.5 % w/w, or Al2O3: 45.5 – 50.5 % w/w, and 650-017-00-8 SiO2: 48.5 – 54 % w/w, b) fibres have a length weighted geometric mean diameter less two standard geometric errors of 6 or less µm) Ammonium dichromate 2151163 Anthracene 120-12-7 Anthracene oil 90640-80-5 Anthracene oil, anthracene low 90640-82-7 Anthracene oil, anthracene paste 90640-81-6 Anthracene oil, anthracene paste, anthracene fraction 91995-15-2 Anthracene oil, anthracene paste, distn. lights 91995-17-4 Arsenic acid 7778-39-4 Benzyl butyl phthalate (BBP) 85-68-7 Biphenyl-4-ylamine 92-67-1 Bis (2-ethyl(hexyl)phthalate) (DEHP) 117-81-7 Bis(2-methoxyethyl) ether 111-96-6 Bis(2-methoxyethyl) phthalate 117-82-8 Bis(pentabromophenyl) ether (decabromodiphenyl ether; DecaBDE) 1163-19-5 Bis(tributyltin)oxide (TBTO) 56-35-9 Boric acid 10043-35-3 and 11113-50-1 Calcium arsenate 7778-44-1 chromium trioxide 1333-82-0 Cobalt (II) sulphate 10124-43-3 Cobalt acetate; cobalt diacetate 71-48-7 Cobalt carbonate; cobalt (II) carbonate 513-79-1 Cobalt dichloride 7646-79-9 Cobalt nitrate; cobalt dinitrate 10141-05-6 Cyclohexane-1,2-dicarboxylic anhydride [1], cis-cyclohexane-1,2-dicarboxylic anhydride [2], trans- 85-42-7, 13149-00-3, 14166- cyclohexane-1,2-dicarboxylic anhydride [3] [The individual cis- [2] and trans- [3] isomer substances and all 21-3 possible combinations of the cis- and trans-isomers [1] are covered by this entry] Diarsenic pentaoxide Compiled with the support of ERA Technology Ltd. www.era.co.uk 1303-28-2 9 www.element14.com/legislation globallegislation@element14.com Diarsenic trioxide 1327-53-3 Diazene-1,2-dicarboxamide (C,C'-azodi(formamide)) 123-77-3 Diboron trioxide 1303-86-2 Dibutyl phthalate (DBP) 84-74-2 Dibutyltin dichloride (DBTC) 683-18-1 Dichromium tris(chromate) 24613-89-6 Diethyl sulphate 64-67-5 Di-isobutyl phthalate 84-69-5 Diisopentylphthalate 605-50-5 Dimethyl sulphate 77-78-1 Dinoseb (6-sec-butyl-2,4-dinitrophenol) 88-85-7 Dioxobis(stearato)trilead 12578-12-0 Disodium tetraborate anhydrous 1303-96-4, 1330-43-4 and 12179-04-3 Fatty acids, C16-18, lead salts 91031-62-8 Formaldehyde, oligomeric reaction products with aniline (technical MDA) 25214-70-4 Formamide 75-12-7 Furan 110-00-9 Henicosafluoroundecanoic acid 2058-94-8 Heptacosafluorotetradecanoic acid 376-06-7 Hexabromocyclododecane (HBCDD) and all major diastereoisomers identified: Alpha- 25637-99-4, 3194-55-6 hexabromocyclododecane Beta-hexabromocyclododecane Gamma-hexabromocyclododecane (134237-50-6) (134237-51-7) (134237-52-8) Hexahydromethylphthalic anhydride [1], Hexahydro-4-methylphthalic anhydride [2], Hexahydro-1- 25550-51-0, 19438-60-9, methylphthalic anhydride [3], Hexahydro-3-methylphthalic anhydride [4] [The individual isomers [2], [3] and [4] 48122-14-1, 57110-29-9 (including their cis- and trans- stereo isomeric forms) and all possible combinations of the isomers [1] are covered by this entry] Hydrazine 302-01-2, 7803-57-8 Lead bis(tetrafluoroborate) 13814-96-5 Lead chromate 7758-97-6 Lead chromate molybdate sulphate red (C I Pigment Red 104) 12656-85-8 Lead cyanamidate 20837-86-9 Lead diazide; Lead azide 13424-46-9 Lead dinitrate 10099-74-8 Lead dipicrate 6477-64-1 Lead hydrogen arsenate 7784-40-9 Lead monoxide (lead oxide) 1317-36-8 Lead oxide sulfate 12036-76-9 Lead styphnate 15245-44-0 Lead sulfochromate yellow (C I Pigment Yellow 34) 1344-37-2 Lead titanium trioxide 12060-00-3 Lead titanium zirconium oxide 12626-81-2 Lead(II) bis(methanesulfonate) 17570-76-2 Methoxyacetic acid 625-45-6 Methyloxirane (Propylene oxide) 75-56-9 N,N,N',N'-tetramethyl-4,4'-methylenedianiline (Michler’s base) 101-61-1 N,N-dimethylacetamide (DMAC) 127-19-5 N,N-dimethylformamide 68-12-2 N-methylacetamide 79-16-3 N-pentyl-isopentylphthalate 776297-69-9 o-aminoazotoluene 97-56-3 Compiled with the support of ERA Technology Ltd. www.era.co.uk 10 www.element14.com/legislation globallegislation@element14.com Orange lead (lead tetroxide) 1314-41-6 o-Toluidine 95-53-4 Pentacosafluorotridecanoic acid 72629-94-8 Pentalead tetraoxide sulphate 12065-90-6 Pentazinc chromate octahydroxide 49663-84-5 Phenolphthalein 77-09-8 Pitch, coal tar, high temp. 65996-93-2 Potassium chromate 7789-00-6 Potassium dichromate 7778-50-9 Potassium hydroxyoctaoxodizincatedichromate 11103-86-9 Pyrochlore, antimony lead yellow 8012-00-8 Silicic acid (H2Si2O5), barium salt (1:1), lead-doped [with lead (Pb) content above the applicable generic 68784-75-8 concentration limit for ’toxicity for reproduction’ Repr. 1A (CLP) or category 1 (DSD); the substance is a member of the group entry of lead compounds, with index number 082-001-00-6 in Regulation (EC) No 1272/2008] Silicic acid, lead salt 11120-22-2 Sodium chromate 7775-11-3 Sodium dichromate 7789-12-0, 10588-01-9 Strontium chromate 7789-06-2 Sulfurous acid, lead salt, dibasic 62229-08-7 Tetraboron disodium heptaoxide, hydrate 12267-73-1 Tetraethyllead 78-00-2 Tetralead trioxide sulphate 12202-17-4 Trichloroethylene 79-01-6 Tricosafluorododecanoic acid 307-55-1 Triethyl arsenate 15606-95-8 Trilead bis(carbonate)dihydroxide 1319-46-6 Trilead diarsenate 3687-31-8 Trilead dioxide phosphonate 12141-20-7 Tris (2-chloroethyl) phosphate 115-96-8 Zirconia Aluminosilicate Refractory Ceramic Fibres where a) Al2O3, SiO2 and ZrO2 are present within the Extracted from Index no. 650- following concentration ranges: Al2O3: 35 – 36 % w/w, and SiO2: 47.5 – 50 % w/w, and ZrO2: 15 - 17 % w/w, b) 017-00-8 fibres have a length weighted geometric mean diameter less two standard geometric errors of 6 or less µm α,α-Bis[4-(dimethylamino)phenyl]-4 (phenylamino)naphthalene-1-methanol (C.I. Solvent Blue 4) 6786-83-0 Cadmium 7440-43-9 Ammonium pentadecafluorooctanoate (APFO) 3825-26-1 Pentadecafluorooctanoic acid (PFOA) 335-67-1 Dipentyl phthalate (DPP) 131-18-0 4-Nonylphenol, branched and linear, ethoxylated [substances with a linear and/or branched alkyl chain with a carbon number of 9 covalently bound in position 4 to phenol, ethoxylated covering UVCB- and well-defined substances, polymers and homologues, which include any of the individual isomers and/or combinations thereof] Cadmium oxide 1306-19-0 Cadmium sulphide 1306-23-6 Disodium 4-amino-3-[[4'-[(2,4-diaminophenyl)azo][1,1'-biphenyl]-4-yl]azo] -5-hydroxy-6- 1937-37-7 (phenylazo)naphthalene-2,7-disulphonate (C.I. Direct Black 38) Dihexyl phthalate 84-75-3 Imidazolidine-2-thione; (2-imidazoline-2-thiol) 96-45-7 Compiled with the support of ERA Technology Ltd. www.era.co.uk 11 www.element14.com/legislation globallegislation@element14.com Trixylyl phosphate 25155-23-1 Disodium 3,3'-[[1,1'-biphenyl]-4,4'-diylbis(azo)]bis(4-aminonaphthalene-1-sulphonate) (C.I. Direct Red 28) 573-58-0 Lead di(acetate) 301-04-2 Please note: The information contained in this guide is of a general nature and is not intended to address the circumstances of any particular individual or entity. Although we endeavour to provide accurate and timely information, there can be no guarantee that such information is accurate as of the date it is received or that it will continue to be accurate in the future. No one should act on such information without appropriate professional advice after a thorough examination of the particular situation. ©2014 Premier Farnell plc. Permission is granted for reproduction in whole or in part providing Premier Farnell plc. is credited. Written in collaboration with ERA Technology Ltd (www.era.co.uk) January 2014 Compiled with the support of ERA Technology Ltd. www.era.co.uk 12