Registration, Evaluation, Authorisation of CHemicals (REACH)

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1 Registration, Evaluation, Authorisation of CHemicals (REACH) LEGAL NOTICE This document contains guidance on REACH explaining the REACH obligations and how to fulfil them. However, readers are reminded that the text of the REACH regulation is the only authentic legal reference and that the information in this document does not constitute legal advice. The BritishToy and Hobby Association does not accept any liability with regard to the contents of this document.

2 What is REACH REACH stands for Registration, Evaluation, and Authorisation of CHemicals. It is the new EU Chemicals Legislation which came into force on 1st June REACH aims to make the people who place chemicals on the market (mainly manufacturers and importers) responsible for understanding and managing the risks associated with their use. It replaces a patchwork of European Directives with a single system. REACH has two main elements: For each ORGANISATION who manufacturers or imports more than a tonne of a substance Every toy vendor who manufacturers or imports more than 1 tonne pa of a substance Intended to be Released or contained in a Preparation must REGISTER that substance with the European Chemicals Agency (ECHA) For each ARTICLE that contains hazardous substances Substances of Very High Concern (SVHC) on a Candidate List or listed in Annex XIV must not be present in any article at excess levels. Substances listed in Annex XVII (Previously part of the Marketing and Use Directive) must not be present in any article at excess levels. REACH also requires that substances falling within the scope of the REACH and the CLP Regulations are NOTIFIED to the European Chemicals Agency for inclusion in an inventory of hazardous substances.

3 Definitions Substance: Single chemical with a unique CAS number or European EINECS number Individual pigments; preservatives; solvents Preparation: Mixture of two or more substances Article: Objects where the shape, surface or design is more important than chemical composition Mixture of solvents; pigments etc to form a preparation. (The containers are an articles, as below) Individual moulded components building up to form an article.

4 Definitions continued Substance of Very High Concern: Substances within the article with a concentration greater than 0.1% known to be high risk Intended Release Substance: Substances that are designed to be released from the article Substances selected by the ECHA and appearing on a SVHC Candidate List Fragrance of a scented dolls, fragrance in play doughs.

5 Key Events Tance that is sub Pre-registration Pre-register with the ECHA (European Chemicals Agency) any substance manufactured or imported over 1 tonne pa that is Intended to be Released from the toy or contained in a Preparation. The Pre-registration period has now closed. If you failed to pre-register substances that you have already supplied, you cannot market that substance after1 st January 2009 without a full Registration. However, there is a provision to pre-register new substances Registration Register with the ECHA (either as an individual company or as a group) any substance manufactured or imported over 1 tonne pa that is Intended to be Released from the toy or contained in a Preparation. Registration will be phased in from June 2008 June 2018 based on annual tonnage imported. tification tify the ECHA the classification and labelling details of any substance that is subject to registration in REACH or is hazardous in the CLP Regulations. tification is from January 2011 Communication Inform customers of the presence of SVHC s on the Candidate list in articles and preparations Inform consumers who ask within 45 days Communication started with the publication date of the first SVHC Candidate List (28 October 2008) or when new substances are added

6 Only Representative Suppliers based outside of the EU can appoint an ONLY REPRESENTIVE (OR) to act on their behalf for the obligations of REACH There are strict rules for Only Representatives: They must be a legal entity in the EU They must be appointed by the supplier, not the importer The scope of the Only Representative is contractually agreed between the supplier and OR. The responsibilities of the Only Representative include Pre-registering and Registering substances Any substance not covered by the Only Representative become the responsibility of the importer.

7 Registration Substances intended to be released in articles or substances in preparations must REGISTERED if the total manufactured or imported by an organisation exceeds 1 tonne per year. Registration will be phased over a number of years based on the weights manufactured or imported by the organisation: 1000 tonnes by tonnes by tonne by 2018 Registration is a complex process that requires manufacturers or importers submit a technical dossier to the European Chemicals Agency to demonstrate that the substance is not hazardous to health or the environment. Registration is based on the use of the substance and may require that groups of organisations submit a joint dossier to the ECHA. Registration can be undertaken by an Only Representative on behalf of a manufacturer or supplier who is based outside of the EU.

8 Pre-registration Substances requiring Registration must have already been PRE-REGISTERED with the ECHA Pre-registration was from 1 June 1 December 2008 Any substance that was not Pre-registered cannot be marketed after 1 January 2009 without full Registration. There is a provision to retrospectively Pre-register if: the substance is new to your organisation or the weight goes above the 1 tonne threshold for the first time.

9 Identifying substances that need to be Registered See BTHA Guidelines on What is an Article in REACH Make inventory of articles that are preparations or include preparations Make inventory of articles which have substances that are intentionally released See BTHA Guidelines on Does an article have substances that need to be Registered? Make an inventory of substances in those preparations Make inventory of substances intentionally released from toy: Determine weight of each substance in each preparation Determine weight of each substance in each toy Multiply this weight by the annual sales for the substance Multiply this weight by the annual sales for the article Combine total annual weight of the same substances from different products further action Prepare to Register Does the weight of any substance exceed I tonne pa? Has the substance been Pre-Registered Cease selling and prepare to Register or substitute with another substance

10 tification NOTIFICATION applies to: Substances requiring registration (i.e. substances that have been Pre-registered) Substances is on the SVHC candidate list or is hazardous under the CLP Regulations or Substances classified as hazardous in a preparation (mixture) that is above the concentration limits for that preparation. tification is not required if the substance has already been registered for that use. tification must be submitted to the ECHA within 1 month of placing on the market from 1 December 2010 (i.e. January 2011) or as new substances are added.

11 tification of substances of very high concern See BTHA Guidelines on What is an Article See BTHA Guidelines on Bill of Materials/ Bill of Substances Make inventory of preparations and substances used in each article See BTHA Guidelines on Substances of Very High Concern (SVHC) Are there any SVHC s? further action Is the SVHC present in the article at a concentration greater than 0.1% by weight? further action See BTHA Guidelines on Substances of Very High Concern (SVHC) Are these SVHC s only found in excluded preparations? further action Is the total weight of each SVHC for ALL your articles greater than 1 tonne? further action NOTIFY your use with the ECHA

12 BTHA Guidelines Following are a series of BTHA Guidelines on how to interpret the regulations. What is an article in REACH? Does an article have substances that need to be Registered? SVHC List Template letters These are based on the guidelines published by European Chemicals Agency as they relate to the toy industry and opinions from industry.

13 BTHA Guideline What is an article in REACH Does the product include packaging materials 1? The packaging (including shipping cartons) are treated as separate articles for REACH Does the product contain more than one item? Are any of the items sold by your company as products in their own right 2? The product is treated as an article for REACH The product is treated as an article for REACH The separately sold items are treated as articles for REACH See BTHA Guidelines on Does an article have substances that need to be Registered? tes: 1 Packaging materials are as defined in the Packaging Waste Regulations 2 Examples are pens sold in sets or individually and doll accessories sold as a part of a set or sold separately.

14 1 Registration is needed if the quantity exceeds 1 tonne pa 2 manufacturerrs of toys like Playdoh and similar modelling compounds are known have received differing official opinions regarding classification as an article or a preparation. Since only the courts have the power to make binding interpretations of REACH, BTHA members should carefully consider whether or not they wish to undertake pre-registration as a safe guard measure. BTHA Guideline Does an article have a substance that needs to be registered From BTHA Guidelines What is an Article in REACH Is the shape, surface and design more relevant than the chemical composition? The article is a preparation / substance or includes a preparation / substance Examples: Hard toys, modelling compound designed to be reshaped 2 The article DOES NOT need to be Registered Is the preparation / substance in a separate container? Is the whole object discarded with the preparation / substances at the end of its life? Examples: Snow globe, thermometer The substance / preparation DOES NOT need to be Registered Is the main purpose of the container used to deliver the preparation / substance? Examples: pencil, felt tip pen, ink pad The substance / preparation DOES need to be Registered 1 (The container does not) Does the preparation / substance leave a trace during normal use? Examples: crayons, The substance / preparation DOES need to be Registered 1 Does the article release a fragrance during use? Examples: fragrance in dough or plastic toys The substance / preparation DOES need to be Registered 1 Does the article intentionally release any residue during use? Examples: coatings intended to be dissolved The substance / preparation DOES need to be Registered 1 Examples: adhesive on self adhesive tape The substance / preparation DOES NOT need to be Registered

15 BTHA Guideline SVHC List The following page shows the complete list of SVHC s on the candidate list and those that are to be elevated to Annex XIV of REACH. Suppliers must NOTIFY the ECHA in 2011 if: Articles contain more than 0.1% by weight and More than 1 tonne of the substance is manufacturer or imported by the supplier Suppliers must inform customers if: Articles containing an SVHC above 0.1% w/w must provide sufficient information to customers to ensure safe use Preparations not classified as dangerous but containing an SVHC above 0.1% w/w in non-gaseous preparations or 0.2% w/w in gaseous preparations must supply a Safety Data Sheet to customers Suppliers must inform any consumer that asks if any SVHC are present in articles or preparations within 45 days of the request. The SVHC list covers all industries that use or manufacturer chemicals. It is not aimed at toys. The BTHA is has published a guide of the SVHC s likely to be found in all materials used to make toys. This is available on the BTHA web site.

16 BTHA Guideline SVHC List Substance Name CAS Number / (EINECS Number) Date introduced to Candidate List Date prioritorised for inclusion to Annex XIV Anthracene /10/09 4,4'- Diaminodiphenylmethane (MDA) /10/09 01/06/09 Dibutyl phthalate /10/09 01/06/09 Cobalt dichloride /10/09 Diarsenic pentaoxide /10/09 Diarsenic trioxide /10/09 Sodium dichromate, dihydrate /10/09 5-tert-butyl-2,4,6-trinitro-m-xylene (musk xylene) /10/09 01/06/09 Bis (2-ethyl(hexyl)phthalate) (DEHP) /10/09 01/06/09 Hexabromocyclododecane (HBCDD) and /10/09 01/06/09 Alkanes, C10-13, chloro (Short Chain Chlorinated Paraffins) /10/09 01/06/09 Bis(tributyltin)oxide /10/09 Lead hydrogen arsenate /10/09 Triethyl arsenate /10/09 Benzyl butyl phthalate (BBP) /10/09 01/06/09 Anthracene oil /01/10 Anthracene oil, anthracene paste, distn. lights /01/10 Anthracene oil, anthracene paste, anthracene fraction /01/10 Anthracene oil, anthracene-low /01/10 Anthracene oil, anthracene paste /01/10 Coal tar pitch, high temperature /01/10 Acrylamide /01/10 Aluminiosilicate, Refractory Ceramic Fibres ( ) 13/01/10 Zirconia Aluminosilicate, Refractory Ceramic Fibres ( ) 13/01/10 2,4-Dinitrotoluene /01/10 Diisobutyl phthalate /01/10 Lead chromate /01/10 Lead chromate molybdate sulphate red (C.I. Pigment Red 104) /01/10 Lead sulfochromate yellow (C.I. Pigment Yellow 34) /01/10 Tris(2-chloroethyl)phosphate /01/10

17 Template Letters Communication is a key part of REACH Information must be supplied by vendors about substances in products or they must appoint an Only Representative. The following pages contain template letters for BTHA members to send to vendors: requesting information about substances in their products -or- confirming that the vendor has appointed an Only Representative The Directive requires that you inform customers about SVHC s in your products and you have 45 days to respond to consumers who ask about SVHC s. The third template letter is provided for BTHA members to use if a consumer requests information about SHVC in their products

18 Template Letter to send to vendors asking them for information Dear [vendor] RE: REACH and CLP Regulations I am writing to you about REACH, the new EU Regulation on the Registration, Evaluation and Authorisation of Chemicals which is now in force and the CLP Regulation that comes into force early next year. These regulations impose a number of obligations on the importer of chemical substances that meet certain criteria. As you are a supplier to our company based outside of the EU, we require that you provide us with information to ensure that we can meet these requirements. REACH has two main requirements: Substances imported by my company in toys or packaging that total 1 tonne per year or more and are Intended to be Released or form a part of a Preparation (mixture) must be registered with the European Chemicals agency. Substances that are defined as hazardous must not be present in any toy or article we place on the market. These are Substances of Very High Concern (SVHC) as listed by the European Chemicals Agency on a Candidate List or substances listed in Annex XVII of REACH which have been consolidated from other EU legislation. In addition, any substance falling into the above categories must meet the revised classification and labelling requirements under the new CLP Regulations and be notified to the European Chemicals agency. These regulations are a tremendous challenge to us and we need to work with you to ensure we are both able to meet the new law and are able to continue our business relationship. To help us to collect the necessary substance data can you please let us know:- The person in your company that deals with REACH and CLP related matters. That you can prepare a list of substances in products manufactured for us and that you will make this information available or Do you have any plans to appoint an Only Representative to deal with substances contained in products you supply to us? In order that we can achieve these requirements, we have to collect data for (the following /attached list of) products we import from you and which intentionally release substances, are included in preparations or include substances that are defined as hazardous. Please use this list to provide :- A full bill of materials for all components in the listed/attached products that you supply to us. For those components that are intentionally released or included in a preparations, a full breakdown of the substances they contain. We will require this information by xx/xxxx/xxxx I must remind you that this information is mandatory for REACH and CLP compliance. If we cannot get this information to the EU authorities by the due dates we will not be able to import the products. If you have any questions please contact /me directly. Yours sincerely,

19 Template Letter to send to vendors who appoint an Only Representative Dear [vendor], RE Appointment of Only Representative I am writing to you about your decision to appoint an Only Representative to undertake your obligations of the EU REACH Regulations. By taking this approach, we understand that you and your Only Representative will undertake the requirements for all substances contained in products imported into the EU by [my company]. These requirements will include, but not be limited to: Confirming that all substances that fall within the scope of REACH have been Pre-registered. Ensuring that substances will be properly Registered with the European Chemicals Agency (ECHA) according to the schedule set out in the REACH Regulations. Take on all the financial obligations required to submit the Registration of each substance. If your products contain a substances that is defined as hazardous, (i.e. contained in the SVHC Candidate List or listed in Annex XVII of REACH) then you or your Only Representative must provide information so that we can: tify the European Chemicals agency by December Provide information to our customers. Respond to any consumer question about SVHC in your products, within 45 days of the original request. Work with you or your Only Representative to replace any SVHC with an alternative substance not on the Candidate List or not contained in Annex XVII of REACH. By appointing an Only Representative, you have agreed to take on these obligations on behalf of [my company]. However, to help us satisfy that these obligations are being met, please supply: The name and address of the Only Representative you have, or intend to, appoint. A person within the Only Representative that we may contact. A confirmation letter from you confirming that the obligations are being met by the Only Representative and a list of products / substances included in your contract with them. A confirmation letter from the Only Representative, addressed to [my company], that they are undertaking this role on your behalf. Yours sincerely

20 Template Letter to send to consumers who ask about SVHC in your products xx/xxx/ xxxx Dear [concerned consumer] Re: Your enquiry about dangerous substances in [toy(s)] Your name Your address Thank you for your recent [letter/ /telephone] call regarding the possible presence of certain dangerous substances in our toys. Firstly let me start by reassuring you that none of our toys contain dangerous substances that might be harmful to a child. For many years, strict EU and UK laws on toy safety makes illegal for toys to contain dangerous substances. REACH, a new piece of legislation not specifically aimed at toys, requires all suppliers of all products should provide information to consumers who ask about the presence of certain categories of dangerous substances in any product. [My company] is aware of the obligations imposed by REACH and we have been working on this with our suppliers for the last XX years. We are very happy to confirm that none of our toys contain any substance that appears in the ECHA SVHC list in amounts that might pose a hazard to children. [Suitable paragraph to end specific to the individual toy company] Yours sincerely, oooooooo If you do have levels above 0.1% then the last paragraph may become; [My company] is aware of the obligations imposed by REACH and we have been working on with our suppliers for the last [XX] years. Whilst [toy(s)] contains [chemical name] which is present on the ECHA list above the level required for notification, it is at a level that does not pose a hazard to children. [Suitable paragraph to end specific to the individual toy company] Yours sincerely,

21 Case Study Bubble Solution Y The following pages show a typical Bill of Material for a simple Bubble Solution and how you would evaluate to see whether it contains: Any substance that needs to be Registered with the ECHA. Any substance that is an SVHC and needs to be tified to the ECHA Any substance that needs to be Communicated to customers and consumers This example also demonstrates the how each of the following are treated: The toy which is treated as an Article in REACH. Packaging which is treated as a separate Article in REACH. The bubble solution that is treated as a Preparation in REACH. The breakdown of a product into its constituent parts is the Bill of Materials (BoM). The breakdown of a Preparation into its constituent Substances is sometimes referred to as a Bill of Substances (BoS). Its function is the same as a BoM. This example a simplified format for a BoM /BoS. The BTHA is devising a format that should meet the joint needs of REACH and the new Toy Safety Directive.

22 Case Study Bubble Solution Set Based on an idea from Bureau Veritas Bill of Material Checklist for Bubble solution set Item# Description Qty Article/ Preparation/ Packaging Material SVHC Colour Part Weight %SVHC in article 1 Bottle 1 pc Packaging PVC White g DEHP 5g 14.3% 2 Cap 1 pc Packaging PE White g 3 Sticker 1 pc Packaging Paper/Ink/ lacquer Multicolour g Each item of packaging is a separate article and the percentage content of any SVHC must be calculated based on the weight of that item of packaging 4 Bubble wand 1 pc Article PE Red g 5 Bubble solution 80 ml Preparation Water/Detergent/ Preservatives Clear g The Bubble Solution is a Preparation a special container in REACH and so the substances that make up the preparation have to be determined. The next page shows the substance breakdown

23 Case Study Bubble Solution Set (2) Based on an idea from: Bureau Veritas Bill of substance for the Bubble solution Bubble Solution (Water, detergent and preservatives) 92.7% of product without packaging Ingredients Material CAS w/w in SVHC Potential for Registration A) Protamide L % tification B) Glycerine % C) Sodium trideceth sulfate % D) Methocel E % E) 1,2 Propenediol % F) Methyl 4-hydroxybenzoate % G) Chloroacetamide (a preservative) % H) Distilled water % tes: A-G) These substances need to be Registered if the total quantity imported by the company exceeds 1 tpa H) Distilled water is a exempt in REACH and so does not need to be Registered A-H) substance is an SVHC so tification is not required

24 BTHA Recommends As REACH is a complex piece of legislation with many aspects still to be clarified, the BTHA recommend: Write to vendors explaining REACH and their role in meeting the legislation. (A template letter format is given later in these guidelines) Get an inventory of Substances contained in Preparations intended to be released Get an inventory of Substances of very high concern in any part on the toy of the substances on SVHC Candidate List. Ensure that any substance that requires REGISTRATION has been Pre-registered. NOTIFY the Chemicals Agency of any Substances of very high concern from 2011 Inform customers of any Substances of very high concern and any consumer who asks within 45 days If the vendor is to appoint an Only Representative, Get details of the Only Representative and keep in the technical file Ensure that you are commercially covered in case of failure of the vendor or Only Representative to meet the REACH obligation

25 Further Information European Chemicals Agency (ECHA) This include the official guidelines on REACH and its implementation Website: Health and Safety Executive (HSE) The UK agency responsible for REACH Website REACHReady A service provided by the Chemical Industries Association giving practical information about REACH Information is free for a basic service. A subscription service is available providing more comprehensive information. There is a special rate for BTHA members Website: BTHA Toy Safety Advice