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  1. REACh A presentation from Bonnie Okeke, Fisher Scientific UK Compliance Manager

  2. REACh background • REACh • Registration, Evaluation and Authorisation and restriction of Chemicals • Why? • Recognises a need to understand and protect the general public from the hazards posed by everyday exposure to chemicals • COSHH in place for professional users • Nothing equivalent for “Joe Public” • Prior to 1981, no requirement for industry to carry safety testing of chemicals prior to release to general market • Environmental implications have also risen to the fore in recent years • Objective? • To understand and eliminate, where possible, the risks associated with use of hazardous chemicals by the general public and their potential impact on the environment

  3. REACh Background cont: • History, some key points: • 1998 – Concerns expressed about current system • 1999 – Stakeholder debate initiated • 2001 – White paper published • 2002 – Draft business impact document published • May to July 2003 – Internet consultation on full draft text initiated • October 2003 – Full REACh proposal is published • December 2006 – REACh EC regulation and Directive published • 1st June 2007 – Legislation goes live!!!

  4. The basics of the Legislation • Applies to chemicals with a demand >1MT pa • Exception to demand limit – substances of very high concern • Hazardous chemicals will be registered for specific uses • Where hazard is considered to be of “very high concern” or volumes are significant, detailed information will be needed to allow the assessment of risk to: • Human Health • The Environment • In some cases, chemicals may be restricted for specific uses or even removed from the market

  5. The process of REACh – Registration • Registration: • What needs to be registered? • Everything with sales >1MT pa • By when? • Pre registration by December 2008 • Registration deadlines then vary based on tonnage quantity – 3 to 11 years • Subsequent registration will require: • Safety information and test results for and uses of the finished product as well as the chemical constituents used in the process of manufacture • Who has responsibility for registration? • The importer or manufacturer, co-operation is encouraged where feasible and data sharing of animal test data will be mandatory.

  6. The process of REACh – the other elements • Evaluation: • Submitted registration data will be evaluated by the Commission • Authorisation: • Limited to substances of very high concern • Carcinogenic, mutagenic, toxic for reproduction, persistent, bio-accumulative and toxic, very persistent and very bio-accumulative. • Will be use specific and within specified safety thresholds • Granted once applicants have demonstrated that the use is adequately controlled and within the safety thresholds. • Where usage takes the chemical outside of the authorised safety thresholds, use will only be allowed when: • Socio-economic analysis (SEA) confirms that advantages of chemical remaining available outweigh the impact of a ban • Substitution plans including, if necessary, R&D programmes to find alternatives have been submitted • Cefic (European Chemical Industry Council) may drive mandatory substitution programmes • The use of authorisable chemicals for non-authorised uses will be illegal!!

  7. REACh – a summary of the legislation • The principal is laudable – reduction of risk, both to humans and the environment. • However……. • The focus is on chemicals in products used in a “home” environment, no recognition of the Laboratory market • Registration is use specific • How many uses can Acetone be put to in a Laboratory? • What level of detail will be acceptable? • Programme is likely to result in some chemicals being withdrawn from the EU market • Costs of registration (including full toxicological testing if not available) will outweigh sales revenue potential, authorisation will require a €54K fee. • Little chance of gaining agreement for use outside of safety thresholds based on SEA arguments

  8. Thermo Fisher response to REACh • Key impacts on Fisher Chemical and Acros product ranges, most Maybridge products fall under 1MT threshold • The challenge – ~19,000 specific chemicals! • Process of pre-registration is beginning • 1,200 potential substances of high concern have been identified, Thermo Fisher offer 500 of these • Key issues: • If we take REACh by the letter of the law: • We need to understand the uses that all 19,000 chemicals are put to • We need to ask the customers what they are using the products for • Ultimately, when customers buy a product, there should be a check re if the use is authorised – use for none authorised uses will be illegal!! • Ultimately, some of the high concern chemicals will disappear because the costs of registration and authorisation will outweigh any commercial benefit

  9. REACh and the key issues for Lab customers • The onus is on the manufacturer/importer • Chemicals will be authorised for a specific use • Customers will need to tell us what their “use” of a chemical is as part of the registration process • ? over the acceptability of “for laboratory applications” as a use • Theoretical risk of breaking the law when a chemical is used for a non registered application where volumes >1 MT pa • Risk of breaking the law when a substance of very high concern is used for a non authorised application • Who polices? • Should the customer be checking that their usage is authorised • Should the supplier be checking that the usage is authorised – process? • Does an external agency police (HSE), if so, how?

  10. REACh summary • Legislation is in it’s infancy, boundaries have not been established. • Implementation time frame is long – 2018 is the deadline for registration of lower demand (1-100 tonne) chemicals • Focus is on the consumer market, not the “B2B” market • Bears no consideration of the Laboratory market and the uses that Chemicals are put to therein • Thermo Fisher’s current stance will be to try and submit registration based on usage being “For Various Laboratory Applications” • Two way dialogue will be needed: • manufacturer customer • It is anticipated that, in the longer term, some chemicals will disappear as a result of this programme