EU legislation: Chemicals REACH

Transcription

1 In the 2007, a new EU policy on chemicals REACH entered into force. Depending on the use of the chemicals substances the REACH legislation sets obligations, differing from the obligation to register chemicals to restrictions on the use of certain dangerous substances. Although EU companies are technically responsible for meeting the obligations under REACH, suppliers outside the EU will be required to provide information on the chemicals used in their products. Overview of this document REACH is a complex matter which is not easy to understand. The Regulation itself is over 500 pages long! In order to make it easier to determine if REACH may have implications for the export of your products to the EU, this document is made up of four sections. Section 1 gives a brief introduction to the legislation and discusses the CBI sectors involved and the applicability of REACH to exporters from outside the EU. If relevant for you, you can go on to Section 2, which describes the main obligations under REACH and the way companies from outside the EU are involved. Annex I presents more detailed information and references on the mentioned topics and Annex II gives useful information sources. The underlined words in this document are hyperlinks. Clicking on an underlined word will lead you to more technical information on the requirements set by REACH on that specific topic in this document and to references to guidance documents from external sources. Please note that this document mainly focuses on the possible relevance of REACH for the CBI target sectors. If you are an exporter of (mixtures of) chemicals or articles containing certain chemicals, you may have obligations under the EU s chemical policy: REACH. Please note that certain product groups, such as food ingredients or pharmaceuticals are exempted from REACH. The possible obligations under REACH for some products may depend on the eventual use. For example, pigments that can be used in food and non-food products. They fall within the scope of REACH when used for non-food products, while they have to meet EU food legislation (and are exempted from obligations under REACH) when used in food. 1. What is REACH and which CBI sectors are involved? Back to overview REACH is the EU legislation on chemicals and their safe use that came into force in June 2007 through Regulation (EC) 1907/2006. REACH establishes one single regime throughout the 27 EU Member States for existing and new substances. It deals with the Registration, Evaluation, and Authorisation and restriction of CHemicals. The registration obligations will be implemented in phases until In what way does REACH affect companies outside the EU? Technically your EU importer is responsible for compliance with REACH. However, your exports to the EU may be affected if your products are covered by the Regulation, since EU companies may have to pass on certain requirements to their suppliers. Which CBI sectors are most likely to be affected by REACH? Producers of substances and/or mixtures, for instance producers of paints and coatings, fine chemicals or cosmetic ingredients, may be indirectly affected by REACH. These (mixtures of) substances can be subject to registration. This effect is indirect because in

2 most cases it is expected that the EU importer will take on the REACH requirements and register substances if necessary, however they may demand information from their suppliers to complete a registration. Substances in articles which are intended to be released during normal use (e.g. the release of perfume from a perfumed eraser) are also considered as substances as such and can be subject to registration. Product groups such as textiles, office and school supplies and electronics are also connected to REACH, since they may contain (hazardous) substances. REACH establishes restrictions on the use, production or placing on the market of some of these substances. Furthermore the use of so called Substances of Very High Concern (SVHC) may require an authorisation. Again, it will be the EU importer who is responsible and he will probably want to know which substances his suppliers use. Communication within the supply chain is a must! As said before, your EU importer is responsible for meeting the requirements under REACH. However, a direct consequence of your EU importer s non-compliance with REACH may be the discontinuation of your exports. It is likely that your EU importer needs hazard data, safe use information and volumes on the chemicals you use and will choose other suppliers if you cannot provide this information. Therefore, an inventory of the substances, mixtures and articles that contain SVHC or substances which will be foreseeably released from the articles will be a very possible requirement from your EU importer. Please note that in case you do not produce chemicals yourself but you buy them, you have to get the specific data from your supplier to make the data you need to provide to your EU importer complete (supply chain management). What can you do? You can wait until your EU importer requests data on the chemicals that you use or are traceable in your product, but you can also anticipate the possible requests by EU importers with the following actions: 1. Ask your buyer for their requirements regarding REACH. 2. Create an inventory of all chemicals used, including raw materials and additional materials being used in your production processes and which can also be found in the final product (i.e. substances, substances in mixtures and/or substances that can be released by the final products). This inventory should include: Name of the substance; Characteristics of the substance (hazard data, safe use information, etc.); Quantity exported to the EU per year; Origin (where does it come from); Final destination (to whom sold). It might be necessary to gather information from your suppliers in order to complete your inventory. 3. Check the website of the European Chemicals Agency to find out if the substances or uses in your inventory are exempted from the registration under REACH. 4. Stay in close contact with your buyer. To whom can you turn with questions? Buyer One very useful source of practical information can be your EU importer. He knows what his obligations are and what he expects from his suppliers to make it possible for him to meet these requirements. European Chemicals Agency (ECHA) ECHA is the EU s authority on REACH. Its website provides information on the Regulation, guidance on REACH provisions, IT tools for REACH uses and Frequently Asked Questions. Member States competent authorities

3 Each EU Member State has appointed a national REACH helpdesk. All national helpdesks van be found here. The CBI CBI s market information database provides frequently updated information on REACH and other market access requirements. Furthermore you can ask specific questions to CBI s helpdesk on marketaccess@cbi.eu. Click here to go to Annex II for useful sources. 2. General obligations under REACH, possibly affecting your export to the EU Back to overview Registration (Mixtures of) substances are subject to registration with ECHA, if they are exported to the EU. The actual requirements depend on the nature of the substance and if the volume is 1 ton per importer per year..substances or mixtures in containers (e.g. printer cartridges) are considered substances and are therefore subject to registration as well. Substances in articles which are intentionally released during their use (e.g. a fragrance in a scented eraser), also have to be registered. If substances fall under the obligation to register, but are not registered they may not be placed on the EU market. Exemptions The obligation to register does not apply to substances used: in medicinal products for human or veterinary use; as a food additive in foodstuffs; as a food flavouring in foodstuffs; as an additive in feeding stuffs; in animal nutrition; substances included in Annex IV and Annex V of the Regulation. temporarily excluded: polymers, however monomers do need to be registered! Pre-registration Until December 2008, chemical producers and importers in the EU had the opportunity to pre-register the chemicals used. Pre-registration provided registering companies with more time to obtain and compile the information necessary to complete the normal registration. Substances that have not been pre-registered need to be registered as a new substance, which is a more complicated process. Click here for a list of pre-registered substances. Click here for more details on the registration obligations in Annex I of this document. Only representative If a substance is not registered by your EU importer, and you use substances subject to registration, you can appoint an only representative to register the substance for you (you cannot register the substance yourself, since you are not an EU based company). Click here for more details on only representatives in Annex I of this document. How are you involved? If you are exporting (mixtures of) substances (e.g. paints and cosmetic ingredients) or articles that intentionally release substances which are not exempted from the obligation to register, it is most

4 likely that your EU importers have already (pre-)registered the substance. However, they might need information from you on the substances you are using, to meet their obligations. For the CBI target group, it is not expected that exporters will have to register substances themselves. However, to avoid the risk of discontinuation of your exports, communication with your importer in this matter is essential. Authorisation In order to import or use substances with properties that are deemed to be of very high concern (the so-called Substances of Very High Concern (SVHC)), for example because they are carcinogenic, persistent in the environment or bioaccumulative, EU companies must apply for an authorisation with ECHA before they may be used or placed on the market. The identification of a substance as Substance of Very High Concern and its inclusion in a Candidate List of SVHC is the first step of the authorisation procedure. Following the identification as SVHC, a substance may be included in the Authorisation list (Annex XIV of the REACH Regulation) and become subject to authorisation. If an SVHC is placed on the Authorisation list companies may send an application to ECHA requesting the authorisation for specified uses of these substances. Notification Companies may have immediate legal obligations following the inclusion of a substance on the Candidate List which are linked to the listed substance on its own, in preparations and articles. One of the obligations is the notification of the substance to ECHA. Notification is providing ECHA with specific information on a substance and its uses in articles. If one of the SVHC placed on the candidate list is present in a product above a concentration of 0.1% (w/w) and the total amount of the substance present in all articles exceeds 1 tonne per year, the use of this substance has to be notified. Therefore EU importers are very keen on knowing if and which SVHC are present in the articles they buy. Click here for more details on the Candidate List, authorisation and notification in Annex I of this document. How are you involved? It is your EU importer s responsibility to apply for authorisation and, if necessary, provide notification of articles and their uses. Again he may need information from you on the substances used. However a possibly more important conclusion that could be drawn from the inclusion of a substance on the candidate list of SVHC is that it should be considered as a sign that these substances are unwanted by the EU. The use of these substances may still be allowed (under conditions) for now, but it is highly probable that the use of these substances will be prohibited entirely in the future. It is therefore advised that you already start searching for alternatives, if you are currently using one of the substances on the candidate list of SVHC. Click here for more information on an international initiative on the substitution of several dangerous substances. Restrictions Restrictions may limit the manufacture, placing on the market or use of a substance within the EU territory.. If restrictions apply to a substance, either on its own or in a mixture or article, any activity with this substance is only allowed if it is in compliance with the restrictions set by Annex XVII of the Regulation. This annex contains the list of all restricted substances, specifying which uses are restricted. The former restrictions set out in the repealed Marketing and Use Directive (76/769/EEC), e.g. the ban on asbestos and restrictions on the uses of certain azo-dyes, have been carried over to REACH. Click here for more details on restrictions and an overview of restrictions relevant for CBIs target sectors in Annex I in this document.

5 How are you involved? If you produce products containing one of the substances included in Annex XVII to the Regulation, you must meet the requirements. Otherwise your product will not be allowed on the EU market. Since most restrictions already existed before REACH, you may not notice any difference. Examples of restrictions include the use of phthalates in toys and childcare products or the ban on asbestos. The CBI has identified the restrictions relevant for their target sectors and included separate documents per subject in the market information database. Last updated: May 2012

6 Annex I: Detailed information and references Back to overview Registration of substances Back to Section 2 Unless explicitly exempted from its scope, REACH requires registration of substances with ECHA if they are manufactured or imported at 1 tonne or more per year. Since June 2008, new substances (so-called non-phase-in substances) have to be registered before being manufactured or imported. Substances that are already on the EEA market (i.e. phase-in substances that have been pre-registered ) benefit from transitional arrangements that allow them to be registered by set deadlines depending on their tonnage and/or hazardous properties. Registration started with the most dangerous substances and then with substances traded in big quantities. Quantities are measured in tonnes per year per producer or importer and per application or use. The larger the quantity, the more test information is needed. Substances traded in quantities of more than 10 tonne/yr per importer need to have a chemical safety report. Type of substances and quantities Final registration date Dangerous substances: 1 December 2010 CMRs (carcinogens, mutagens and reproductive toxins) 1 tonne/yr PBTs (persistent, bioaccumulative and toxic substances) 100 tonne/yr vpvbs (very persistent and very bioaccumulative substances), same PBTs Substances 1000 tonne/yr 1 December 2010 Substances 100 tonne/yr 1 June 2013 Substances 1 tonne/yr 1 June 2018 Substances 1 tonne/yr No registration needed New substances 1 June 2008 onwards Only Representative REACH allows manufacturers from outside the EU to pre-register and register their chemicals. This is possible by appointing a representative within the EU who will act on behalf of the manufacturer outside the EU. An only representative can represent one or several non-eu companies. Click here for EU guidance on registration. Authorisation and Notification of Substances of Very High Concern(SVHC) Back to Section 2 Substances of very high concern include substances which are: Carcinogenic, Mutagenic or toxic to Reproduction (CMR) classified in category 1 or 2; Persistent, Bioaccumulative and Toxic (PBT) or very Persistent and very Bioaccumulative (vpvb) according to the criteria in Annex XIII of the REACH Regulation; and/or Identified, on a case-by-case basis, from scientific evidence as causing probable serious effects to humans or the environment of an equivalent level of concern as those above (e.g. endocrine disrupters).

7 At time of publication the Candidate List of SVHC contained 84 substances. Please note that substances are added to the Candidate List of SVHC frequently. To maintain up-to-date with the latest list, it is advised to check ECHA s website on SVHC on a regular basis. Direct obligations following from inclusion of a substance on the candidate list are: From the date of inclusion: EU suppliers of articles which contain substances on the Candidate List in a concentration above 0.1% (w/w) have to provide sufficient information to their clients or upon request to a consumer within 45 days of the receipt of the request. This information must ensure safe use of the article and as minimum contain the name of the substance. From 1 June 2011: EU producers or importers of articles have to notify ECHA if their article contains a substance on the Candidate List. This obligation applies if the substance is present above 0.1% (w/w) and its quantities in the produced/imported articles are above 1 tonne in total per year per company. For substances included in the Candidate List on or after 1 December 2010, the notifications have to be submitted no later than 6 months after the inclusion. Click here for ECHA s page on the Candidate List of SVHC. Substitute It Now (SIN) As mentioned before, inclusion of a substances in the Candidate List of SVHC is a clear sign that that particular substance should be considered unwanted and alternatives should be used where possible. To speed up the substitution of dangerous substances by safer alternatives, ChemSec (The International Chemical Secretariat) has developed its own list of substances which should be considered SVHCs based on the criteria established by the REACH Regulation (the SIN-list). The latest version of this list (May 2011) contains 378 substances. Although this list has no legal consequences, the industry may see it an advanced warning for restrictions to come and even some EU Member States governments advise to use this list when developing criteria for public procurement. Click here for ChemSec s website on SIN. Authorisation Back to Section 2 SVHC will be gradually included in Annex XIV of the REACH Regulation. These substances have hazardous properties. The aim of authorisation is to ensure that risks from SVHCs are properly controlled and that these substances are progressively replaced by suitable alternative substances or technologies, where these are economically and technically possible. There is no tonnage threshold for a substance to be subject to authorisation. Once included in Annex XIV, the substances cannot be placed on the market or used after a to be set date (the so-called sunset date ) unless authorisation is granted to the EU company using the substance, or placing it on the market.

8 Substances listed for authorisation At the time of publication, fourteen substances subject to authorisation were included in Annex XIV to REACH. Substance Sunset date musk xylene 21 August ,4`-diaminodiphenylmethane- MDA 21 August 2014 hexabromocyclododecane - HBCDD 21 August 2015 bis(2-ethylhexyl)phthalate - DEHP 21 February 2015 benzylbutylphthalate BBP 21 February 2015 dibutylphthalate DBP 21 February 2015 Diisobutyl phthalate (DIBP) 21 February 2015 Diarsenic trioxide 21 May 2015 Diarsenic pentaoxide 21 May 2015 Lead chromate 21 May 2015 Lead sulfochromate yellow (C.I. Pigment Yellow 34) 21 May 2015 Lead chromate molybdate sulphate red (C. I. Pigment Red 104) 21 May 2015 Tris (2-chloroethyl) phosphate (TCEP) 21 August ,4-Dinitrotoluene (2,4-DNT) 21 August 2015 To get authorisation the EU company has to prove that the risks from the use of the substances are either adequately controlled or justified on socio-economic grounds. Furthermore he has to show that no alternatives are available. Authorisation will only be granted on a case-by-case basis for a limited period and will be reviewed after that period. Please note that there is no obligation for authorisation for SVHC in articles imported from outside the EU, although the obligation to notify the presence of these substances still applies. Click here for EU guidance on authorisation. Restrictions Back to Section 2 REACH foresees a restriction process to regulate the manufacture, placing on the market or use of certain substances within the EU territory if they pose an unacceptable risk to health or the environment. Such activities may be limited or even banned, if necessary. The restriction is designed as a safety net to manage risks that are not addressed by the other REACH processes. Any substance on its own, in a preparation or in an article may be subject to restrictions. Restrictions of a substance can apply to all uses or to specific uses. All uses of a restricted substance which are not specifically restricted are allowed under REACH, unless they are subject to authorisation or other legislation regulating their use. There is no tonnage threshold for a substance to be subject to restriction. Annex XVII of REACH contains the list of all restricted substances and specifies which uses are restricted. CBI has identified the following restrictions relevant for their target sectors and included separate documents per substance in its market information database: Asbestos in products Azo dyes in textile and leather articles Benzene in toys Cadmium in several products Creosote oil in wood products Flame retardants in textiles Lead in paints Mercury in measuring devices Monomer vinyl chloride used as aerosol propellant Nickel in piercings, ornaments and clothing accessories Nonyl phenols and ethoxylates

9 PAHs in extender oils and tyres OctaBDE in products Phthalates in toys and childcare articles Substances in decorative articles Ugilec and DBBT in several products Wood preserved with arsenic Annex II: Useful sources Back to overview The European Chemicals Agency website: The REACH helpdesk of the European Chemicals Agency will give advice to companies in Third (non-eu) Countries (including developing countries). Contact them with your questions. It will generate an answer much quicker and easier than by you burying yourself in all the available information! Other issues provided at the ECHA website: The Understanding REACH section gives an overview of the Regulation Navigator tool which will assist EU importers and Only Representatives to find out their obligations and how to fulfil them Extensive guidance on REACH provisions IT tools for REACH users and how to operate them Frequently Asked Questions (in general) Leaflet European chemicals legislation, information for exporters to Europe Simplified REACH guidance ECHA published three simplified guidance documents specifying which substances are covered under the REACH chemical rules, what data needs to be registered, requirements for handling dossiers and safety assessments. The three guidance in a nutshell documents are the first in a series of planned simplified guidelines providing an overview of the REACH requirements. Forthcoming guidance will cover areas such as data sharing, monomers and polymers, research and development, classification and labelling. Click here for the guidance in a nutshell documents. CBI s market intelligence: The document on REACH in the database is frequently updated. Furthermore the database gives detailed information on restrictions and other information related to REACH, such as: the Classification, Labelling and Packaging of chemicals (CLP). The National helpdesk in the country of your EU importer If you can not find sufficient advice, you should consider consulting CBI through marketaccess@cbi.eu. Related documents Please find below an overview of other legislative and non-legislative REACH related requirements. Some of the requirements are shortly highlighted in this document. More details however, can be found in the CBI database under the following document titles: Legislation: EU legislation: (new) Globally Harmonized System for the classification, packaging and labelling of chemicals (GHS) EU legislation: Asbestos in products EU legislation: Azo dyes in textiles and leather articles EU legislation: Benzene in toys

10 EU legislation: Cadmium in several products EU legislation: Creosotes in wood products EU legislation: Flame retardants in textiles and garments EU legislation: Lead in paints EU legislation: Mercury in measuring devices EU legislation: Aerosol propellants in spray cans EU legislation: Nickel in clothing, jewellery and accessories EU legislation: Nonyl phenols and ethoxylates EU legislation: PAHs in extender oils and tyres EU legislation: OctaBDE in products EU legislation: Phthalates in toys and childcare articles EU legislation: Oil lamps and liquid substances in decorative articles EU legislation: Ugilec and DBBT in several products EU legislation: Wood preserved with arsenic Non-legislation EU buyer s requirements: Supply chain management This document was compiled for CBI by CREM B.V. Disclaimer CBI market information tools: