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REACH SAFE HANDLING AND USE OF CHEMICALS?. Annika Hammar, Katie Fulton, Gavin Brar, Jake White. OUTLINE. Background and main features Economical aspects Analysis . BACKGROUND. Entered into force 2007 800 pages in the Official Journal Applies directly in all member states
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REACHSAFE HANDLING AND USE OF CHEMICALS? Annika Hammar, Katie Fulton, Gavin Brar, Jake White
OUTLINE Background and main features Economical aspects Analysis
BACKGROUND Entered into force 2007 800 pages in the Official Journal Applies directly in all member states Protect human health and the environment
MAIN FEATURES Wide definition of ”substances” Exeptions, e.g. radioactive substances Registration, Evaluation, Authorisation
MAIN FEATURES Registration Duty for producers and importers Managed by ECA 1 ton/year or articles containing substances above a certain treshold 9000 substances
MAIN FEATURES Evaluation Dossier evaluation- ECA - Evaluate registrations Substance evaluation - Member states - Necessity of additional controles
MAIN FEATURES Authorisation Ensure good functioning of the internal market Assuring that substances of very high concerns are properly controlled If possible: replace substances by suitable alternatives
MAIN FEATURES Restrictions If unacceptable risk to human health or the Environment
ECONOMICAL ASPECTS • Prior to REACH, it was left to public authorities to test chemicals contained in products • Since 1993, only 140 chemicals have been selected for risk assessment • Originally, around 100,000 ‘old’ chemicals traded before 1981 were exempt from testing • Only 3,000 new chemicals have been introduced since 1981.
ECONOMICAL ASPECTS • REACH will ensure that any chemical produced or imported in significant quantities is tested • Existing rules oblige companies to test new chemicals - even if they only produce 10kg. • REACH will ensure that many of the old chemicals are also tested
THE DOWNSIDE • Cost of compliance with the new legation is to be incurred by the producer or the importer • May lead to businesses operating outside of Europe • Huge increase in animal testing • " 3.9 million more animals could be used for testing” • Not "ethically defensible". 4. MEPs wish to promote alternative methods of testing
THE UPSIDE • Stable chemicals = less adverse healthcare effects • Registration = cheaper and quicker • European trade unions have joined environmentalists in arguing for strong legislation
THE UPSIDE 4. Reduction of environmental risks 5. Reduction of risks to human health 6. Benefits for industry
THE FIGURES • Will COST industry between 2.8bn and 5.2bn, rising as high as 12.8bn Euros, over 11 years. • Will SAVE Europe 54bn Euros over 30 years • University College London has come up with an even higher figure - 284bn Euros over 30 years
EVALUATION • Stifle innovation and hinder production of beneficial material • Up to 10% of chemIcals and chemicalcontainingproductscould be removed • Distort global trade and commerce
EVALUATION But • the system is designed to ban/restrictonly the most harmful substances And • is it not essential for human health and the environment that these are?
EVALUATION • Disclosure of confidential business information Or • Cost and adminstrativeburden • the Commission’s Review of REACH in 2013
EVALUATION • The report highlighted the impact which it had on small and medium sizedenterprises (SMEs)as a problem So • Availability of guidance and Substance Information Exchange Forums
EVALUATION • Mainlyfocuses on the impact of REACH on the EU chemicalsindustry And • Ignorant of the impact on otherdownstreamusers
EVALUATION • Chemical mixtures do not belong to a single regualtory group • Transectorial nature poses a major challenge for REACH Regulation
EVALUATION • Has received the ‘thumbs up’ from the European Commission in their report (published 2013) • Commission concluded REACH is: “delivering its main objectives, including health and environmental protection, competitiveness and innovation”.
EVALUATION Not all are unanimously positive… • EEB (European Environmental Bureau): “failure to promote the substitution of hazardous chemicals and green chemistry as a driver of innovation” • At the current rate, it will take up until 2060 to include all 1500 of the EU market’s high hazard substances into REACH’s ‘candidate list’ (compare 2020 deadline intended originally)
EVALUATION EEB report in October 2012: • “the performance of the new regulatory framework is failing to meet its objectives” • “Out of the 1,283 substances already recognised under the Classification and Labelling Regulation as CMR substances (Carcinogenic, Mutagenic or toxic to Reproduction), 84 have been formally recognised as Substances of Very High Concern (SVHC) under REACH, and almost no new substances have been restricted in use” (by July 2012, only one restriction had been approved, illustrating the slow progress of REACH).
SVHC’s • Substances of Very High Concern are chemicals for which it has been proposed that the use within the EU be subject to authorisation under the REACH Regulation • Listing of a chemical as an SVHC is the first step for restriction of use of a chemical • The lack of progress in listing harmful chemicals as SVHC’s under REACH has been a centre of criticism from the EEB
NANOTECHNOLOGY AND REACH’s FUTURE • Nanomaterials have novel hazardous properties, some of which are not known yet • Legislating of REACH had concluded before it was considered whether nanomaterials should be included • Nanosubstances are used for numerous consumer and environmental applications
NANOTECHNOLOGY AND REACH’s FUTURE • After 10 years of drafting, Commission would like to avoid revising the regulation itself – has offered to amend the annexes • While ECHA has published very technical guidance for those who register nanomaterials, only silver nanoparticles appear on the list of substances for assessment • No plans for an EU register of products that contain nanomaterials • Academic consensus: its treatment of nanomaterials will put “REACH’s objectives to the test”