REGULATION OF CHEMICALS IN EUROPE – REACH

REGULATION OF CHEMICALS IN EUROPE – REACH Thursday December 8 2011 Herman Autrup 1 CHALLENGES – SAFETY OF CHEMICALS Chemicals in commerce 100.000 TSCA compounds 82.000 Food additive 8.600 Cosmetic ingredients 3.400 Pharmaceuticals 1.800 Pesticides ingredients 1.000 USA EPA 2010 2 PRIORITY SETTING Tier 1 Production volume (HPV) Number of producers Use categories Tier 2 Consumer use scenarios Chemical properties Bioavailability 3 EU REGULATION OF CHEMICALS Registration Evaluation Authorisation CHemicals 4 BEFORE 2008- EC 793/93 Existing chemicals - substances on the market 010171- 180981 – European Inventory of Excisting Commercial Chemical Substances (EINECS) New chemicals – compounds on the market after 180981 Responsibilities – Public authorities for existing chemicals – 141 high volume chemicals (MS RAR, ECB, SCHER, EC) New chemicals to be tested at volumes as low as 10 kg/yr 5 REGULATION 793/93 Environmental and Human risk assessment  workers  consumers  man exposed indirectly via the environment 6 RECOMMENDATIONS i There is a need for further information and/or testing ii There is at present no need for further information and/or testing and for risk reduction measures beyond those which are being applied already iii There is a need for limiting the risks; risk reduction measures which are already being applied shall be taken into account 7 Regulation (EC) No 178/2002 • Article 7 - Precautionary principle – 1. In specific circumstances where, following an assessment of available information, the possibility of harmful effects on health is identified but scientific uncertainty persists, provisional risk management measures necessary to ensure the high level of health protection chosen in the Community may be adopted, pending further scientific information for a more comprehensive risk assessment 8 DGSANCO HEALTH AND CONSUMER PROTECTION SCIENTIFIC COMMITTEES: CONSUMER PRODUCTS (SCCP) HUMAN AND ENVIRONMENTAL RISK (SCHER) EMERGING AND NEWLY IDENTIFIED HEALTH RISKS (SCENIR) EFSA (Parma, IT) EMEA (London, UK) 9 OBJECTIVES of REACH  Protection of human health and the environment  Maintenance and enhancement of the competitiveness of the EU chemical industry  Prevention of fragmentation of the internal market  Increased transparency  Integration with international efforts  Promotion of non-animal testing 10 [...]... Location of activity: indoor, outdoor, ventilation • Risk management measures (default none) 20 Worker exposure – methanol (Tier 1) Generic processing – closed system (PROC 2) Type of setting – industrial Form of substance – liquid Duration of exposure > 4 hrs (default) Location indoor without ventilation Inhalation exposure 66.8 mg/m3 Dermal exposure 1.4 mg/kg/day Other worker functions – 267-333...HOW WILL REACH WORK ?  All substances are covered by the regulation  Registration – manufacturers/importers obtain relevant informations  Reduce testing on vertebrate animals – data sharing  Better information on hazards and risks  Evaluation - ECHA (Helsinki)  Authorisation – risk adequately controlled, socioeconomic benefits outweigh risk,... than 1000 tonnes is transported full dossier is required 24 REDUCE ANIMAL TESTING Data sharing 3R principles reduce refine replace ECVAM – European Center for Validation of Alternative Methods 25 SUBSTANCES 1 to 10 T per year Toxicological data on skin and eye irritation in vitro, skin sensitation and bacterial mutagenicity Skin/eye test donot need to be conducted if chemical is corrosive If positive... with UF No evidence of absorption and no toxicity in 28-day study 28 SUBSTANCE IN ARTICLES REACH requies all substances that are intended to be released from articles during norml and foreseeable conditions of use to be used according to normal and reasonable foreseable conditions to be registered Substances of very high concern present in articles above the concentration limit of 0.1% weight by weight... possible carcinogenic effect 18 EXPOSURE SCENARIOS 1 Identify uses of chemical Manufacturing, industrial use, service life, waste 2 Identify routes of potential exposure for each use 3 Develop exposure scenario for each use 19 EXPOSURE SCENARIOS-WORKERS • Work process – descriptor • Time of activity • % of substance used • Form of substance (gas, liquid, solid) • Vapour pressure, dustiness • Operational... chemically modified – minerals, ores, crude oil, vegetable oil 13 REGISTRATION Manufacturers and importers must submit registration for substances in quantities of 1 tonnes or more/yr exemptions medicinal products, naturally occuring substances, (polymers) Technical dossier – 1 tonne or more Chemical safety report – 10 tonne or more Responsibility of manufacturer og importer to collect information on the... compounds) Deadline 6 years for 100-1000 t Deadline 11 years for 10-100 t and 1-10 t 32 REACH - DEADLINES 33 SUBSTITUTION Substitute a compound with an less toxic alternatives No special criteria – substances requiring an authorization Based upon NOEL/ MOS Alternatives may be associated with risk A substance banned in Europe can re-enter the European Market in finish articles Case by case basis 34 RISK ANALYSIS... Documents the hazard  Classification of substanse  Describes exposure scenarios, manufacturing, use and life-cycle risk management procedures, including safety data sheets CSR should be developed for all uses, by importer/producer as well as downstream users Joint submission of registration dossier 16 CLASSIFICATION – safe levels 17 GLOBAL HARMONIZED SYSTEM Acute toxicity – oral (LD50) T R28 up to 25 mg/kg... 200-2000 mg/kg Skin irritation Xi R38 Significant inflammation of the skin which persist for at leat 24 hours after an exposure period up to 4 hrs (rabbit) Carcinogenic substances Category 1 T R45 &T R49 Substances known to be carcinogenic to man Category 2 (same label) Substances which should be regarded as they are carcinogenic to man Category 3 (Xn R40) Substances which cause concern for man owing to possible... EVALUATION Dossier evaluation: Compliance test Checking of testing proposals Substance evaluation: in collaboration with MS development of action plan – MS to evaluate priority substances 30 AUTHORISATION Required for compounds of high concern CMR category 1 and 2 PBT (persistent, bioaccumulative and toxic) vPvB (and classified as R50-R53) Scientific evidence – case-by-case basis ECHA will publish list annually . REGULATION OF CHEMICALS IN EUROPE – REACH Thursday December 8 2011 Herman Autrup 1 CHALLENGES – SAFETY OF CHEMICALS Chemicals in commerce 100.000 TSCA compounds. properties Bioavailability 3 EU REGULATION OF CHEMICALS Registration Evaluation Authorisation CHemicals 4 BEFORE 2008- EC 793/93 Existing chemicals - substances on the market 010171- 180981 – European Inventory of Excisting. competitiveness of the EU chemical industry  Prevention of fragmentation of the internal market  Increased transparency  Integration with international efforts  Promotion of non-animal testing 10 HOW