Pexa REACH Bulletin Version 1.0

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1 This bulletin is the first in a series which should cover the 10 year period of implementation of REACH, it is intended to provide assistance to Pexa s trading partners on REACH issues and to communicate Pexa s own policies and activities with regard to REACH. Further issues will be produced when significant new information becomes available. For updates please register your interest at our contact address reach@pexa.co.uk. Background REACH is the EU Regulation 1907 of 2006 on the Registration, Evaluation, Authorisation and Restriction of Chemicals, this came into force on 1 st June It is considered the most far reaching regulation yet produced by the EU Commission and it will be extremely important to our industry for the next 10 years. The regulation runs to >800 pages and this short bulletin is intended to highlight the most important features for clients of Pexa. We hold a complete copy of the regulation on file and can send a copy on request. As a member of the British Coatings Federation (BCF), Pexa has been actively following the development of REACH since it was first proposed. THE BCF keeps us up to date with the requirements of REACH and its impacts on our industry (surface coatings and treatments for aerospace, defence and high tech applications). We are aware of our obligations under REACH and we are taking action to ensure that we respond to each new stage of REACH as it takes effect. Affected Products REACH identifies different categories of materials which are affected. For the purpose of this bulletin, the most important 2 categories are - Substance, naturally occurring or manufactured chemical element or compound. - Preparation, mixture or solution of 2 or more substances. This would include a paint or a metal alloy for example. Other categories are identified but for our industry these are less important. It is Substances which must be registered and the requirement is that any substance used in a concentration higher than 0.1% and >1000kg per year must be registered. An important distinction must be made between substances, which must be registered, and products - including proprietary products and finished goods which are not registered as they are preparations. Substances which are not registered will not be allowed to be supplied within the EU. Clearly therefore, products/preparations which contain unregistered substances will not be allowed to be supplied. Affected Parties REACH deals with the supply chain by identifying so called actors who occupy different positions in the supply chain. For the purpose of this bulletin the most important of these are importer, manufacturer and downstream user. The manufacturer or importer of the substance is the actor with the obligation to register the substance. The downstream user does not have this obligation. However the downstream user may be affected, should the manufacturer/importer not take steps to register substances which are contained in products used by the downstream user, as products containing unregistered substances will no longer be available. Pexa is taking steps with its suppliers to ensure that all substances are registered and that continuity of supply is not affected. Registration Process REACH is divided into 3 important phases - Pre-registration - Registration - Authorisation Page 1 11/03/2008 Pexa Ltd

2 During 2008, pre-registration is the most important phase. This is a data collection phase whereby all substances will be preregistered by all manufacturers and/or importers. All substances must be pre-registered on the European Chemicals Agency (ECHA) IUCLID5 database (on line) in the period 1 st June 2008 to 30 th November Substances which are not pre-registered will have to immediately be registered in order to be supplied in the EU. Pre-Registration Pexa is collating data on all products which it supplies within the EU and is requiring the manufacturer or importer of the products to ensure that all the substances used within those products are pre-registered (where the volume exceeds 1000 Kg/ann.). In case the manufacturer or importer is not taking steps to register those substances, or where Pexa is itself the importer, then Pexa itself will pre-register the substances. Pexa works with major international product manufacturers and we have a high degree of confidence that they are taking all the necessary steps to ensure pre-registration of their substances. They will be keeping Pexa closely informed of their progress in preregistration. We have a programme to obtain written confirmation from all of our suppliers that substances are pre-registered, registered and (if necessary) authorised. In cases where the manufacturer will/can not disclose what substances are present, or is not taking steps to pre-register its substances, then Pexa requires 6 months notice of such a situation in order to allow alternative products to be qualified by downstream users. We do not expect the supply of any important materials to be affected and, in case supply is affected, we will be taking steps in plenty of time to notify downstream users and to ensure that suitable alternatives are available. For pre-registration of a substance the key data required are as follows - Substance name and EINECS number - Details of the pre-registering entity (e.g. Pexa) - Annual tonnage band of the substance - Envisaged registration deadline Some important exclusions There is no formal pre-registration document or record which can be provided as evidence of pre-registration. The database of all pre-registered substances will be made public by the ECHA no later than January There is no requirement at this stage to identify the end use of the substances. This will happen at a later date when the ECHA has agreed a harmonised system for describing end use applications. There is no regulatory requirement for a manufacturer to provide a list of all substances used in their products. Current MSDS produced in accordance with Annex II of REACH are already REACH compliant. MSDS may be amended more frequently in future to meet the evolving requirements of the regulations. Pre-registration can only be carried out by a European entity. Defence Exclusion, the UK MoD wishes to make use of an exclusion for defence equipment where issues of secrecy are concerned or the continued availability of certain materials necessary for the provision of defence requirements. This exclusion is complex and anyone wishing to investigate further is recommended to contact the SBAC Pexa is intending to make sure all of its substances are registered, whether or not for a defence end use, unless it is proven absolutely necessary for them not to be. Registration & Authorisation The ECHA expects around 100,000 substances to be pre-registered, they will publish a complete list no later than January 2009 and this will be available on their website. Page 2 11/03/2008 Pexa Ltd

3 Registration of substances will occur according to a timetable related to the quantity and hazard of the substance. A fully detailed timetable will therefore not be available until the list of all substances is produced. Registration will occur between 2008 and 2018, with timings dependent upon hazard and quantity used. Subsequent issues of this bulletin should be able to make the timetable clearer. Registrants of each substance will be allocated into a Substance Information Exchange Forum (SIEF) with other registrants of the same substance. This is to promote sharing of data and to reduce the cost to each party of registering and authorising substances. A Registration Dossier will be submitted to the ECHA and this will contain substantial data as to the chemical nature of, and hazards posed by the substance. The registration and authorisation phases are those which begin to incur significant costs for the manufacturer or importer. It is at this stage that we may see cost/benefit equations starting to have an impact on the availability of products; as the costs of registering or authorising substances may be higher than is economically justifiable. This may have a disproportionate effect on the aerospace industry, which typically has a higher dependence on smaller volume exotic materials and also on older qualified technologies which may not be considered to have a long term future. In these cases the manufacturer may choose to withdraw the product/substance rather than register particular substances present in the product. These decisions will be made between now and 2018 depending on the quantity and hazardous nature of such substances. It is Pexa s aim to identify such cases in good time and to make sure that we are able to offer qualified alternatives in such cases. Or that we can provide substantive evidence that we are importing less than the 1000Kg limit per year of any such substances. Pexa will be working very closely with its suppliers to make sure that all our downstream users are kept fully up to date with any such cases; as of now we are not aware of any such cases. During the registration phase the ECHA will identify Substances of Very High Concern which will be subject to authorisation or restriction, these will include Category 1 CMRs and PBT or vpvb which are usually identified in section 3 of the MSDS. We do not expect any products which we supply to be included in the first stage of SVHC. Such substances will effectively be phased out. Contact Pexa s principal contact for REACH issues is Mr Jim Rowbotham, for updates and any other information please use our REACH mailbox at reach@pexa.co.uk Disclaimer: This bulletin is intended as a guideline for assistance in dealing with issues arising out of REACH. It is not intended as a substitute for full compliance with any party s obligations in law. We do not accept any liability for the use of the information provided nor for any losses arising from its use. Page 3 11/03/2008 Pexa Ltd

4 Appendix 1 Useful Websites - The UK government agency to assist industry in complying with REACH. The British Coatings Federation. Society of British Aerospace Companies - The REACH Directive. - Airbus Information on REACH - Download a copy of the REACH interpretation guidelines. European Chemicals Agency. - DEFRA. UK HSE Competent Authority. - European Chemicals Bureau. - The EU Commission. The EU Commission. -The EU Commission. - The EU Commission. Page 4 11/03/2008 Pexa Ltd

5 Appendix 2 Glossary of Terms Cat 1/2 CMR CSA DNEL EC ECHA EEA EU MS PBT PNEC REACH SIEF tpa vpvb Category 1 or 2 classification as a CMR Carcinogenic, mutagenic or reprotoxic substance Chemical Safety Assessment Derived no effect level European Commission European Chemical Agency European Economic Area European Union Member States Persistent bioaccumulating and toxic (in aquatic environment) Predicted, no-effect concentration Registration, Authorisation and Restriction of Chemicals Regulation Substance Information Exchange Forum Tonnes per annum Very persistent and very bioaccumulating (in aquatic environment) Page 5 11/03/2008 Pexa Ltd