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Preparing SMEs for REACH

Preparing SMEs for REACH. Enterprise Ireland, Glasnevin, 30/3/2006. QUESTIONS TO BE ANSWERED TODAY:. What is REACH? How does it effect my company? What does my company need to do?. What is REACH?. REACH stands for R egistration, E valuation and A uthorisation of CH emicals.

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Preparing SMEs for REACH

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  1. Preparing SMEs for REACH Enterprise Ireland, Glasnevin, 30/3/2006

  2. QUESTIONS TO BE ANSWERED TODAY: • What is REACH? • How does it effect my company? • What does my company need to do?

  3. What is REACH? • REACH stands for Registration, Evaluation and Authorisation of CHemicals. • It is a new regulation designed to manage and control the potential hazards to human health and the environment of the manufacture and usage of chemicals within the EU. • It has important implications for the manufacturers, importers and downstream users of individual chemicals, chemicals in preparations and chemicals in “articles”.

  4. REACH jargon explained: • Manufacturer/Importer – M/I • Downstream user – (DU) a user [in the widest sense] of a chemical produced by the Manufacturer/Importer. • Competent Authority – (CA) the national body within a Member State responsible for the implementation of REACH. In Ireland, the Health and Safety Authority (HSA).

  5. REACH Jargon continued: • CMR – Carcinogenic, Mutagenic and Repro toxic. • PBT – Persistent, Bioaccumulative and Toxic. • vPvB – Very Persistent, very Bioaccumulative. • R50-53 – Particular Risk phrases. • The above are descriptions of the effects of some chemicals. REACH defines the properties that put a chemical into one of these categories. Any chemical falling into these categories will only be available for use with Authorisation!

  6. REACH Jargon Contd. • CSR – Chemical Safety Report – required for registration of substances manufactured in quantities >10 tonnes. A report that details the hazards associated with a particular chemical. It must contain a Chemical Safety Assessment (CSA). The CSA takes into account Risk Management Measures (RMM) put in place by the M/I or recommended by them to the DU. • ES – Exposure Scenarios – How will people and the environment be exposed to the substance? M/I and DU – two way communication required.

  7. REACH Jargon contd. • SDS – Safety Data Sheet – as per current SDS, but more comprehensive and thorough information required. Will include information from the CSR - exposure scenarios and risk reduction measures. • RIP – REACH Implementation Project – Research projects that were “dry runs” at testing the various aspects of REACH. • The Chemicals Agency –a new EU body in Helsinki that will be responsible for the overall management of REACH.

  8. WHY REACH • There are concerns over the lack of information on the potential hazards and risks to human health and/or the environment from the production and usage of existing and future chemicals. • Current system is inefficient.

  9. How will REACH work? • All chemicals manufactured/imported in the EU in quantities >1 tonne must be Registered. This applies to individual substances, substances in preparations and substances in “articles”. • Registration involves the submission of a technical dossier of information on the substance to the Chemicals Agency. The details of what is required are given in the REACH Annexes. • A substance can be Registered by a consortium of companies. (Reduces costs to individual companies).

  10. How will REACH work? • Evaluation will be carried out in two steps: • Dossier evaluation – carried out by the Chemicals Agency. • Substance evaluation – carried out by the Competent Authority (in Ireland, the HSA). Overseen by the Chemicals Agency.

  11. How will REACH work? • Authorisation will be required for a company to produce or put on the market a “substance of very high concern” – i.e. a substance that falls into any of the following categories; CMR, PBT, vPvB, or R50-53. • Authorisation will only be granted where industry shows that either (a) risks to human health and the environment are “adequately controlled” or (b) socio-economic benefits outweigh risks. • Substitution study required. • Authorisation is for a fixed time.

  12. How does REACH effect my company? • If you are a M/I and you manufacture/import substances in quantities >1 tonne, you will have to register that chemical. • You can register the chemical by yourself, or as part of a consortium. The Chemicals Agency encourages the formation of consortia via the Substance Information Exchange Forum (SIEF). • If you are a DU, you will need to supply information up the supply chain to the M/I on how you use a substance supplied by them.

  13. How does REACH effect my company? • The cost of REACH may mean that substances with tight profit margins may no longer be produced. This will have implications for formulators. • Substitution is not always a simple, easy or cheap measure.

  14. How does REACH effect my company? • Some of the findings of a study carried out by Forfas: • REACH will generate significant financial costs for chemical manufacturers in Ireland – but costs spread over 11 years. • The cost to DUs in Ireland will be significantly higher than that estimated for the upstream manufacturing industry. • The ICT hardware industry and SMEs, as predominantly downstream users, are likely to feel the greatest impact. • Due to the presence of speciality chemicals in Ireland’s chemical industry, the potential to form consortia and share registration costs is likely to be constrained.

  15. Key Sectoral Impacts H – High; M – Medium; L – Low. N.B. Broad assessments: Every Company should assess the implications of REACH for themselves.

  16. What does my company need to do? • If you are a M/I, start gathering information together on your chemicals. • Are there gaps in the information? • Do any of the substances you produce fall into any of these categories: CMR, PBT, vPvB, R50-53? • How do your downstream users use your chemicals? • Do you want/need to be part of a consortium/consortia to register your substances?

  17. What does my company need to do? • If you are a DU: • Is there a danger that an essential chemical may be withdrawn by my upstream manufacturer/importer? • Does my M/I understand REACH and what it may mean for them and their chemical product portfolio? • How do I use the chemicals supplied by my M/I and do they understand how I use it? • Can I substitute a relatively low risk chemical for one of very high concern?

  18. REACH – Be Prepared! • Thank You for your Attention!

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