REACH REGULATION: the new management of chemicals in Europe and operational tools. R egistration. E valuation. A Ch. uthorisation.

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1 REACH REGULATION: the new management of chemicals in Europe and operational tools R egistration E valuation A Ch uthorisation emicals

2 Index of topics Set of rules before REACH Regulation REACH REGULATION REGISTRATION EVALUATION AUTHORISATION RESTRICTION Shared-Information-Down Stream Users Classification and Labelling

3 Index Set of rules before REACH Regulation REACH REGULATION REGISTRATION EVALUATION AUTHORISATION RESTRICTION Shared-Information-Down Stream Users Classification and Labelling

4 Set of rules before REACH Regulation existing substances, that are substances placed on the market before 18 th of September 1981: they are listed in EINECS (European INventory of Existing Commercial chemical Substances), introduced with directive 67/548/EEC; Oltre 4300 new substances, placed on the market after 18 th of September 1981: they are listed in ELINCS (European LIst of Notified Chemical Substances), introduced with directive 67/548/EEC; About substances classified as «dangerous» (Annex I, directive 67/548/EEC); 40 groups of substances «restricted» on the marketing and use (corresponding to approximately 900 substances), in application of directive 76/769/EEC; 141 priority substances, substances insert in the evaluation and control of the risks program of existing substances (Regulation (EEC) 793/93)

5 EC Number Source State 2xx-xxx-x EINECS Official 3xx-xxx-x EINECS Official 4xx-xxx-x ELINCS Official 5xx-xxx-x NLP Official

6 Index Set of rules before REACH Regulation REACH REGULATION REGISTRATION EVALUATION AUTHORISATION RESTRICTION Shared-Information-Down Stream Users Classification and Labelling

7 REACH Regulation N. 1907/2006 Official Journal of the European Union L396 of 30 th December 2006 Current from 1 st June 2007 Registration, Evaluation, Authorisation, Restriction of Chemicals

8 REACH Regulation N. 1907/2006 Official Journal of the European Union L396 of 30 th December 2006 Current from 1 st June 2007 Registration, Evaluation, Authorisation, Restriction of Chemicals

9 European Economic Area (EEA) members Iceland, Liechtenstein and Norway take part of the European Economic Area (EEA) till Is now active the legislative process to get the implementation of REACH Regulation in EEA countries within a short period. When the REACH Regulation will be implement by the EEA members, the imports of chemicals will be considered like an intra- Community trade. European Union (without Croatia) Iceland, Norway, and Liechtenstein Provisional EU members

10 European Free Trade Association (EFTA) members Switzerland takes part of European Free Trade Association (EFTA) witch doesn t comply REACH Regulation. Importers of a substance from Switzerland (country belonging to EFTA, not EEA) shall comply with any condition imposed by Agency like any other importer. During the last Meeting Group of Competent Authorithies, Switzerland representatives expressed the willingness of implent REACH Regulation in their system (in part or totally). European Union (without Croatia) Iceland, Norway, and Liechtenstein Provisional EU members

11 Aim and scope Mapping all chemical substances circulating in Europe (such substances on their own, in mixtures or in articles ); To ensure a high level of protection of human health and the environment, through a description of chemical-physical, toxicological and ecotoxicological properties, including the promotion of alternative methods for assessment of hazards of substances; It is based on the principle that it is for manufacturers, importers and downstream users to ensure that they manufacture, place on the market or use such substances that do not adversely affect human health or the environment. Its provisions are underpinned by the precautionary principle; To enhance competitiveness and innovation. (no data no market (Art. 5)) To make a correlation between substance, hazard and use (concept of Identified use); Increased safety in the workplace; Warranty maximum of transparency and information; REGISTRATION The encouragement and, in some cases, the guarantee of REPLACING the most problematic substances with less dangerous substances or technologies, placed in the context of technically and economically feasible alternatives; RESTRICTION AUTHORIZATION The simplification and harmonization of legislation of Member States (Regulation, Directive does not). SDS

12 MANIFACTURER any natural or legal person established within the Community who manufactures a substance within the Community IMPORTER any natural or legal person established within the Community who is responsible for import a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition DOWNSTREAM USER (DU) any natural or legal person established within the Community, other than the manufacturer or the importer, who uses a substance, either on its own or in a mixture, in the course of his industrial or professional activities. A distributor or a consumer is not a downstream user. a mixture or solution composed of two or more substances

13 EXCLUSION from the application field of REACH Regulation (Art.2) Radioactive substances (Council Dir. 96/29/Euratom) Substances, on their own, in a mixture or in a article, which are subject to customs supervision, provided that they do not undergo any treatment or processing, and which are in temporary storage, or in a free zone or free warehouse with a view to reexportation, or in transit Non-isolated intermediates Waste (Dir. 2006/12/CE) Member States may allow for exemptions from this Regulation in specific cases for certain substances, on their own, in a mixture or in an article, where necessary in the interests of defence Moreover shall be exepted from Registration and Evaluation: polimers, substances included in Annex IV and V, substances exported and re-imported Shall be exepted from REACH also: medicinal products for human or veterinary use, cosmetic product (as finished product; active principles and other included substances are not exepted), medical devices, food and feedingstuffs.

14 (Art. 75, TITLE X) 27 MS s MB ECHA RAC SEAC MSC Forum MS = EU Member States MB = ECHA Management Board RAC = Committee for Risk Assessment SEAC = Committee for Socioeconomic Analysis MSC = Member State Committee Forum = Forum for Exchange of Information on Enforcement Tasks of the Agency Centrally manage the technical and scientific aspects and administrative processes too. Ensuring the consistency of decisions at EU level. Giving support to the competent authorities of the Member States and the applicant for registration

15 Interface ECHA Member States- European Commission MB RAC 27 MS(CA)s REACH 27 MS(CA)s CLP Observers from non-eu countries, international organizations and stakeholders ECHA SEAC MSC Forum CARACAL (Competent Authority of REACH e CLP) An expert group which advises the European Commission and ECHA on questions related to REACH and CLP EUROPEAN COMMISSION

16 Implementation of REACH Regulation in Italy Ministry of Economic Development Ministry of Environment and Protection of Land and Sea COMPETENT AUTHORITY Chemical Substances Centre Regional Environmental Protection Agency Local health Institute for Environmental Protection and Research

17 Index Set of rules before REACH Regulation REACH REGULATION REGISTRATION EVALUATION AUTHORISATION RESTRICTION Shared-Information-Down Stream Users Classification and Labelling

18 MANIFACTURER & IMPORTER 1. Registration Dossier The registrant of a substance needs to compile all the required information in a registration dossier, which consists of two main components: A TECHNICAL DOSSIER, always required for all substances subject to the registration obligations A CHEMICAL SAFETY REPORT (CSR), required if the registrant manufactures or imports a substance in quantities of 10 ton/year. The registration dossier has to be prepared using the IUCLID 5 software application. Once the dossier has been created with IUCLID 5, it has to be submitted to ECHA through REACH-IT e- platform. 2. Payment of the corresponding fee according to Title IX

19 (I) Technical Dossier Manufacturers and importers have to collect all existing available information on the intrinsic properties of a substance as well as on its manufacture, uses and exposure. The technical dossier contains information about: The identity of the substance Information on the manufacture and use of the substance The classification and labelling of the substance Guidance on its safe use (Robust) study summaries of the information on the intrinsic properties Proposals for further testing, if relevant For substances registered in quantities between one and ten tonnes, the technical dossier also contains exposure related information for the substance (main use categories, type of uses, significant routes of exposure) ANNEX VII >1 ton/year ANNEX VII e VIII >10 ton/year ACCORDING TO THE TONNAGE / YEAR MOVED ANNEX VII, VIII e IX >100 ton/year ANNEX VII, VIII, IX e X >1000 ton/year

20 (II) CHEMICAL SAFETY REPORT (CSR, Annex I) When a substance is manufactured or imported in quantities greater than 10ton/year is required CHEMICALS SAFETY ASSESSMENT (CSA) that is documented in a CHEMICAL SAFETY REPORT (CSR) The CSA AIMS to identify the conditions of use under which a substance can be used safely throughout its entire life-cycle. IDENTIFIED USE THREE MAJOR STEPS: HAZARD assessment EXPOSURE assessment RISK CHARACTERISATION

21 1. HAZARD assessment Collection and evaluation of all available and relevant information on the intrinsic properties of the substance, on the manufacturing and uses, and on the related emissions and exposures. Where existing information is insufficient, additional information has to be generated. The objective is to IDENTIFY the HAZARDS of the substance, assess their potential effects on human health and the environment, and determine the threshold levels for exposure considered as safe (the so called NO-EFFECT LEVELS) Does the substance meet the criteria for classification as DANGEROUS or to be considered a PBT (Persistent Bioaccumulative e Toxic)/vPvB (very Persistent very Bioaccumulative)? NO CSA ends here YES Two additional steps are required to complete CSA DNEL (Derived No Effects Level) Vary depending on the exposure pattern : the population likely to be exposed (i.e. workers, consumers the frequency and duration of the exposure (e.g. single exposure or continuous exposure) the route of exposure: dermal, inhalation or oral PNEC (Predicted No Effects Concentrations) Needs to be determined for each environmental sphere (aquatic, terrestrial, atmospheric, sewage treatment, food chain)

22 2. EXPOSURE assessment The process of measuring or estimating the dose or concentration of the substance to which humans and the environment are or may be exposed, depending on the uses of the substance (EXPOSURE LEVEL) EXPOSURE SCENARIOS (ESs) cover all identified uses and life stages of the substance 3. RISK CHARACTERISATION The levels of exposure are compared with the threshold levels for each effect DNEL PNEC PEC NO RISK EXP

23 ITERATION Yes

24 CSR & DU When a DU receives an extended safety data sheet with exposure scenarios for registered substances HAS TO Check whether the exposure scenarios cover your uses: SCALING (simple algorithms in the ES which enable the DU to demonstrate that he works in the conditions foreseen by the registrant s ES) Check whether the conditions of safe use correspond to the conditions under which you use the substance Communicate to the supplier possible variations provided that the supplier accept to modify the CSR YES Differences? NO No problem Stop activity Ask to external experts to prepare the CSR. Careful choice! Substitute the substance Look for another supplier Prepare himself his own CSR and communicate with ECHA

25 Substances to be registered: 1. Any substance, either on its own or in one or more mixture(s), manufactured or imported in quantities of 1 ton/year; 2. Any manufacturer or importer of a polymer shall submit a registration to the Agency for the monomer substance(s) or any other substance(s), that have not already been registered by an actor up the supply chain, if both the following conditions are met: (a) the polymer consists of 2 % (w/w) or more of such monomer substance(s) or other substance(s) in the form of monomeric units and chemically bound substance(s); (b) the total quantity of such monomer substance(s) or other substance(s) makes up 1 ton/year 3. Any producer or importer of articles shall submit a registration to the Agency for any substance contained in those articles, if both the following conditions are met: (a) the substance is present in those articles in quantities totalling over one tonne per producer or importer per year; (b) the substance is intended to be released under normal or reasonably foreseeable conditions of use.

26 when a substance is intended to be manufactured in the Community by one or more manufacturers and/or imported by one or more importers Data MUST be shared for the same substance in the cases of: Information involving tests on vertebrate animals, Information not involving tests on vertebrate animals (ex. chimical-physical tests). Substance Information Exchange Forum The joint submission is possible for any natural or legal person established within the Community.

27 Article in REACH Regulation Definition: an object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition

28 To determine if this is indeed an article as defined by REACH is necessary to distinguish between: Article with substance intended to be released Textile cosmetics (active principles released) Substance/Mixture inside a container Article with substance not intended to be released Scented articles Substance/Mixture

29 Articles with substance intended to be released (Art. 7(1) ) Any producer or importer of articles shall submit a REGISTRATION to the Agency for any substance contained in those articles, if both the following conditions are met: (a) the substance is present in those articles in quantities totalling over one tonne per producer or importer per year; (b) the substance is intended to be released under normal or reasonably foreseeable conditions of use. A submission for registration shall be accompanied by the fee required in accordance with Title IX.

30 Articles with substance not-intended to be released (Art. 7(2) ) Any producer or importer of articles shall NOTIFY the Agency, in accordance with paragraph 4 of this Article, if a substance meets the criteria in Article 57 (SUBSTANCE OF VERY HIGH CONCERN SVHC) and is identified in accordance with Article 59(1) (insert in the candidate list), if both the following conditions are met: (a) the substance is present in those articles in quantities totalling over one tonne per producer or importer per year; (b) the substance is present in those articles above a concentration of 0,1 % weight by weight (w/w).

31 In the REACH Regulation the Substances of Very High Concern (SVHC) are substances meeting criteria for classification in : 1. carcinogenic, mutagenic or reproductive toxic (CMR), in the hazard class 1 and 1B 2. persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vpvb) in accordance with the criteria set out in Annex XIII of the Regulation, 3. substances such as those having endocrine disrupting properties or those having persistent, bioaccumulative and toxic properties or very persistent and very bioaccumulative properties, which do not fulfil the criteria of points (d) or (e) for which there is scientific evidence of probable serious effects to human health or the environment which give rise to an equivalent level of concern to those of other substances listed in points (a) to (e) and which are identified on a case-by-case basis in accordance with the procedure set out in Article 59

32

33 Question 4a: If the substance/mixture were to be removed or separated from the object and used independently from it, would the substance/mixture still be capable in principle (though perhaps without convenience or sophistication) of carrying out the function defined under step 1? Question 4b: Does the object act mainly (i.e. according to the function defined under step 1) as a container or carrier for release or controlled delivery of the substance/mixture or its reaction products? Question 4c: Is the substance/mixture consumed (i.e. used up e.g. due to a chemical or physical modification) or eliminated (i.e. released from the object) during the use phase of the object, thereby rendering the object useless and leading to the end of its service life? YES > NO = SUBSTANCE/MIXTURE + ARTICLE

34 Question 5a: If the substance/mixture were to be removed or separated from the object, would the object be unable to fulfil its intended purpose? Question 5b: Is the main purpose of the object other than to deliver the substance/mixture or its reaction products? Question 5c: Is the object normally discarded with the substance/mixture at the end of its service life, i.e. at disposal? YES > NO = ARTICLE

35 Question 6a: Does the object have a function other than being further processed? Question 6b: Does the seller place the object on the market and/or is the customer mainly interested in acquiring the object because of its shape/surface/design (and less because of its chemical composition)? Question 6c: When further processed, does the object undergo only light processing, i.e. no gross changes in shape? Question 6d: When further processed, does the chemical composition of the object remain the same? YES > NO = ARTICLE

36 Exercise: Printer cartridge Thermometer

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