《Presentation REACH ‐ Implementation,Application & Impact》由会员分享，可在线阅读，更多相关《Presentation REACH ‐ Implementation,Application & Impact（11页珍藏版）》请在金锄头文库上搜索。
1、22/09/20101REACH ImplementationREACH Implementation, Application & ImpactTom Holmes Agchem Project Consulting Ltd International reach through local focus09/08/20101APC Offer a complete service for the plant protection biocide and chemical industriesprotection, biocide and chemical industries Covers
2、40 countries 3 main strengths: * Scientific : chemists, agronomists, toxicologists & environmental experts * Geographic : experts with strong local knowledge &Geographic : experts with strong local knowledge & contacts * Strategic & project managers : business experts with hands on experienceInterna
3、tional reach through local focus09/08/2010222/09/20102REACH The new EU chemicals regulation Background on REACHBackground on REACH What its objectives are, why and how it is being implemented, How it is being applied, particularly with respect to reducing in vivo testing and the role of QSARS What i
4、mpact it will have on the toxicity prediction09/08/2010International reach through local focus3REACH does not apply to Biocides Pesiticides Pesiticides Pharmaceuticals (human and animal) Food Waste Substances occuring in nature. e.g. Water, oxygen, certain noble gasses, minerals and ores (lhilldifi
5、d)(so long as not chemically modified). Other materials. e.g. Cellulose pulp, Polymers (except where they contain residues of certain monomers)International reach through local focus09/08/2010422/09/20103Objectives Address shortcomings of an old system, which was a patchwork of different directives
6、accreted over time. Most chemicals grandfatheredin with little or no data only 4% registered since 1981 had data submitted, now considered insufficient. Public authorities, rather than producers, produced the risk assessments No obligations on downstream users to produce RAs h ito cover their uses.
7、Slow Effectively meant Europe lagged behind other regions of the world in terms of safetyInternational reach through local focus09/08/20105PORDS/PPORDSStill need to make PORD/PPORD for it lti l il diexperimental materials including: pharmaceuticals pesticides biocidesInternational reach through loca
8、l focus09/08/2010622/09/20104Implementation of 2006/1907 REACH Regulation cant look at REACH in Isolation part of a “matching set” of regulationsmatching set of regulations. All incorporate principles of the Animal welfare directive 86/609/EEC. Biocides 98/8/EEC GHS CLP Regulation 1272/2008 incorpor
9、ates and adapts 67/548/EEC, 1999/45/EC PPP Regulation 1107/2009International reach through local focus09/08/20107Animal welfare directive 86/609/EEC Registrants are not obliged to generate in vivo data for C&L where scientifically satisfactory alternative method can be used and it is demonstrable it
10、 comesup with the same result. Soon to be superceded by new directive:International reach through local focus09/08/20108 Soon to be superceded by new directive: Obliged to use other methods before get to in vivo testing. Text agreed 8/9/201022/09/20105Potentially (?) a huge deficit of data to genera
11、te for REACH review subs Anxiety about fitting through labs Nd ti iit bt tti Need to minimise vertebrate testing (European directive 86/609/EEC) Vertebrate testing under REACH to be a last resort Alot of data actually existed having been generated for other systems around the world. Provision of oth
12、er avenues to avoid testing.International reach through local focus09/08/20109Avenues to avoid generation of vertebrate data Regulations 134/2009 “zero or low ”exposure” Reach Guidance use of (Q)SAR, readacross (analogues vs groups), calculation Vertebrate data sharing obligatory SIEFs In vitro alte
13、rnatives In vitro alternativesInternational reach through local focus09/08/20101022/09/20106Regulation 134/2009 “zero or low exposure”Data can be omitted for REACH when: In all usescenarios exposures are negligible or In all usescenarios exposures are negligible, or well below DNEL/PNEC, where the D
14、NEL/PNEC is robust and takes into account the uncertainty of the data to be omitted Strictly controlled conditions apply through the life cycle or materials, such that no exposure occursoccurs. Incorporation of test substance into an article such that no exposure can take place (substance not releas
15、ed in life cycle of the article).International reach through local focus09/08/201011Avoiding vertebrate in vivo testing calculation E.g. Prediction of the properties of Mixtures and “preparations” Although calculation of NOAELs tricker For more information see the CLP regulationInternational reach t
16、hrough local focus09/08/20101222/09/20107Avoiding vertebrate in vivo testing readacross (analogues vs groups) Readacross essence of (Q)SARs Use analogous chemicals (structural similarities) Grouping of chemicals (e.g. REACH has adopted OECD groupings)adopted OECD groupings)International reach through
