PLANNING FOR REACH 2018 AS A NON-EU COMPANY

Transcription

1 PLANNING FOR REACH 2018 AS A NON-EU COMPANY Joyce Borkhoff Vice President, Chemicals Group Intertek Scientific & Regulatory Consultancy

2 AGENDA Overview of REACH Requirements Specific to Non-EU Companies Key Elements and Definitions Only Representation 03 Registration, Authorization and Restriction 04 Articles Under REACH 05 Non-EU to EU REACH Supply Chain Examples 06 Developing a REACH Strategy 07 Hurdles and Learnings

3 01 OVERVIEW OF REACH REQUIREMENTS SPECIFIC TO NON-EU COMPANIES

4 REACH OBLIGATIONS FOR NON-EU COMPANIES Does REACH reach you? Are my products subject to REACH? NO Do I have obligations under REACH? NO Do you have requirements under REACH? Do I need to pre-register? NO Do I need to complete an inquiry? NO Do I need to prepare a Registration/Joint-Registration? NO Do I need to prepare a chemical safety report? NO Who will be affected? EU chemical manufacturers YES Importers of substances, preparations and articles YES Downstream Users YES Does REACH influence your business? Will I still be able to market my products in Europe? NO YES

5 LEGAL CONTEXT Import Means the physical introduction into the customs territory of the EU. Importer Means any natural or legal person established within the EU who is responsible for import. Supplier of a substance or a preparation Means any manufacturer, importer, downstream user or distributor placing on the market a substance, on its own or in a preparation Article 6 Save where this Regulation provides otherwise, any manufacturer or importer of a substance, either on its own or in one or more preparation(s), in quantities of 1 tonne or more per year shall submit a registration to the Agency. Responsibility for the management of the risks of substances should lie with the natural or legal persons that manufacture, import, place on the market or use these substances.

6 REACH RESPONSIBILITIES A non-eu Manufacturer is NOT allowed to submit a Registration in the EU Two options to ensure REACH compliance of products/substances 1. Rely on the importers OR Move the material and the REACH obligation to the Importer Importer will have the ability/flexibility to move the material on his own Manufacturer loses control of the material as soon as it comes into the EU 2. Appoint an Only Representative Manufacturer maintains complete control of the supply chain, distributing the material to the EU downstream users directly REACH obligations go directly to the Only Representative Will take care only of REACH obligations Never sees material Non-EU manufacturer would keep control of the distribution in the EU

7 02 KEY ELEMENTS AND DEFINITIONS

8 REGULATION (EC) NO 1907/2006 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 18 DECEMBER 2006 concerning the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (as amended) 8

9 REACH KEY ELEMENTS 01 Registration Manufacturers and Importers to submit information to ECHA on all substances produced / imported into EU in amount 1 tpa Evaluation Competent Authorities to assess what is submitted by Industry. Authorization Manufacturers / Importers to submit an authorization dossier for identified substances and specific uses. 04 Restriction <<Safety Net>>, proposed by Competent Authorities to limit specific substances. REACH Regulatory Overview, M. Corazza, April

10 IMPORTANT DEFINITIONS Phase-in substances Were already being manufactured or placed on the market before the entry into force of the REACH Regulation on June 1, 2007 and were not notified according to Directive 67/548/EC Substances in EINECS (European Inventory of Existing Chemical Substances), present on the Community market on September 18, 1981; Substances manufactured in the EU and not placed on the market (export only or intermediates); No Longer Polymers (NLP). Non phase-in substances All substances that do not fulfil any of the criteria for phase-in substances. 10

11 REACH - ROLES Manufacturer Any natural or legal person established within the EU who manufactures a substance within the EU Importer Any natural or legal person established within the EU who is responsible for import. Downstream User (DU) Any natural or legal person established within the EU, who is not a manufacturer or importer, but who uses a substance, either on its own or in a mixture, in the course of his industrial or professional activities. 11

12 NON-EU REACH SUPPLY CHAIN ROLE DEFINITIONS Non-EU Manufacturer Legal entity responsible for manufacturing substances outside the EU. Non-EU Formulator Legal entity responsible for formulating mixtures outside the EU. Non-EU Distributor Legal entity solely responsible for storing and placing on the market substances/mixtures for third parties outside of the EU. (Trading companies) 12

13 OVERVIEW ROLES VS OBLIGATIONS Perform Registration Apply for Authorisation Provide SDS to customers Communication along supply chain Manufacturer Importer/Only Representative Downstream user (1) Distributor ( ) 13

14 DEFINITIONS Preparation: a mixture or solution composed of two or more substances. Polymer: (a) a simple weight majority of molecules containing at least three monomer units which are covalently bound to at least one other monomer unit or other reactant; and (b) less than a simple weight majority of molecules of the same molecular weight (Mw). Article: 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

15 IMPORT SCENARIOS THE IMPORTER CONCEPT Non-EU Manufacture US EU Import Poland Import Germany 10 tonnes 100 tonnes/ 50 tonnes sourced from France Manufacture/ Import France 100 tonnes/ 10 tonnes

16 REACH SCENARIO 1 (STANDARD) Non-EU Manufacture US EU Import Poland Import Germany 10 tonnes 100 tonnes/ 50 tonnes sourced from France (Pre)registration Inquiry Registration (10 tonnes) (Pre)registration Inquiry Registration (100 tonnes) DU Manufacture/ Import France 100 tonnes/ 10 tonnes (Pre)registration Inquiry Registration (110 tonnes)

17 REACH SCENARIO 2 ( THIRD PARTY ) Non-EU Manufacture US EU Import Poland Import Germany 10 tonnes 100 tonnes/ 50 tonnes sourced from France (Pre)registration Inquiry Registration (10 tonnes) (Pre)registration Inquiry Registration (100 tonnes) DU Manufacture/ Import France 100 tonnes/ 10 tonnes (Pre)registration Inquiry Registration (110 tonnes) Third Party Representative

18 THIRD PARTY REPRESENTATIVE (ARTICLE 4) Any manufacturer, importer, or where relevant downstream user, may, whilst retaining full responsibility for complying with his obligations under this Regulation, appoint a third party representative for all proceeding under Article 11, Article 19, Title III and Article 53 involving discussions with other manufacturers, importers, or where relevant downstream users. In these cases, the identity of a manufacturer or importer or downstream user who has appointed a representative shall not normally be disclosed by the Agency to other manufacturers, importers, or, where relevant, downstream users. e.g. will not be disclosed to participants in the SIEF Article 11: Joint Submission of data by multiple registrants Article 19: Joint submission of data on isolated intermediates by multiple registrants Article 53:Cost sharing for tests without an agreement between registrants and/or downstream users

19 REACH SCENARIO 3 ( ONLY REPRESENTATIVE COMPANY LEGAL ENTITY) Non-EU Manufacture US EU DU Import Poland Import Germany 10 tonnes 100 tonnes/ 50 tonnes sourced from France DU Manufacture/ Import France Only Representative 100 tonnes/ 10 tonnes (Pre)registration Inquiry Registration (220 tonnes)

20 REACH SCENARIO 4 (ONLY REPRESENTATIVE SEPARATE LEGAL ENTITY) Non-EU Manufacture US Manufacture/ Import France EU Import Poland DU Import Germany DU 100 tonnes/ 10 tonnes (pre)registration Inquiry Registration (for 100 tonnes manufactured) 10 tonnes 100 tonnes/ 50 tonnes sourced from France DU Only Representative appointed by US Manufacturer (pre)registration Inquiry Registration (120 tonnes)

21 ONLY REPRESENTATIVE OF A NON-COMMUNITY MANUFACTURER (ARTICLE 8) 1. A natural or legal person established outside the Community who manufactures a substance on its own, in preparations or in articles, formulates a preparation or produces an article that is imported into the Community may by mutual agreement appoint a natural or legal person established in the Community to fulfil, as his only representative, the obligations on importers under this Title. 2. The representative shall also comply with all other obligations of importers under this Regulation. To this end, he shall have a sufficient background in the practical handling of substances and the information related to them and, without prejudice to Article 36, shall keep available and up-todate information on quantities imported and customers sold to, as well as information on the supply of the latest update of the safety data sheet referred to in Article If a representative is appointed in accordance with paragraphs 1 and 2, the non-community manufacturer shall inform the importer(s) within the same supply chain of the appointment. These importers shall be regarded as downstream users for the purposes of this Regulation. Please note, Non-EU distributors are not mentioned in Article (1) and can not appoint an only representative, i.e. must be a formulation activity involved

22 ONLY REPRESENTATIVE Covered under REACH Article 8 Appointed by a manufacturer/formulator to fulfill the obligations of an importer under the REACH Regulation, including pre-registration, inquiry, and registration. Formation of a legal instrument to appoint the Only Representative Substances covered should be clearly defined as part of the OR agreement. e.g., Schedule A Non-Community manufacturer/formulator MUST inform the importer(s) within the same supply chain of the appointment of the OR. Development and distribution of letter and record keeping OR must keep available and up-to-date information on quantities imported and customers sold to, as well as information on the supply of the latest update of the safety data sheet. Ensures that Principal s customers and the other actors in the supply chain are secure in relying on the registrations and pre-registrations submitted by the Only Representative. Requires that OR and Principal will develop process for volume tracking/reporting by importer

23 03 REGISTRATION, AUTHORIZATION AND RESTRICTION

24 Registration 24

25 REACH REGISTRATION - EXEMPTIONS Exempt from REACH Radioactive substances; Substances in customs supervision; Non-isolated intermediates; Substances in transport; Wastes (Dir. 2006/12/EC); Substances of defence interest. Exempt from registration only Medicinal products; Veterinary medicinal products Medical devices; Food or feeding stuff; Annex IV & V substances; Polymers; Substances recovered in EU; If your substance is exempt from registration obligation there is no need submit a dossier Re-imported substances if already registered by an actor up the supply chain. 25

26 REACH REGISTRATION COSMETIC EXEMPTIONS Cosmetic Regulation (EC) No 1223/2009 prohibits the placing on the market of cosmetic products, or products containing ingredients, which have been tested on animals to meet the requirements of that regulation using a method other than a validated alternative method. Fully in force March 2013 European Commission therefore published: 1. Registrants of substances that are exclusively used in cosmetics may not perform animal testing to meet the information requirements of the REACH human health endpoints. The exception is any testing required to assess the risks from exposure to workers. 2. Registrants of substances that use the substance also for non-cosmetic uses (i.e. mixed-use substances) are permitted to perform animal testing, as a last resort, for all human health endpoints. 3. All registrants (whether or not they only use the substance for cosmetic purposes) are permitted to perform, as a last resort, for all environmental endpoints. ECHA Factsheet ECHA-14-FS-04-EN 26

27 REACH REGISTRATION COSMETIC EXEMPTIONS If the substance is only used in cosmetics, in general, testing for human health endpoints can be adapted, i.e. waived if: The substance is used solely as a cosmetic ingredient; and The testing would not be necessary to fulfil the REACH requirements for assessment of worker exposure. Potential relevant worker exposure includes manufacture; formulation; packaging. Possibility to adapt information may arise when: 1. The cosmetic product is imported in its finished state and not further processed within the EEA (i.e. no identified worker exposure) 2. With the exception of life-cycle stage, which covers the use as a cosmetic product, the substance is otherwise handle only under strictly controlled conditions and worker exposure can be excluded. Technical details on how to indicate such waivers in the registration dossier are described in ECHA s Q&As. ECHA Factsheet ECHA-14-FS-04-EN 27

28 REACH REGISTRATION MONOMERS & POLYMERS Polymers are exempted from registration, but their monomers and other substances have to be registered Polymer manufacturers/importers will have to register monomers if the polymer consist of >2% of a monomer and if: The monomer has not already been registered up their supply chain; That monomer makes up 1tpa. If the monomer is imported alone or as part of a polymer the importer is responsible for registration: Monomers are not considered as on-site or transported isolated intermediates. Polymer manufacturers/importers may have to register other substances present in the polymer: e.g. end-groups, cross-linkers, additives. REACH Regulatory Overview, M. Corazza, April

29 REACH REGISTRATION RE IMPORT Substances registered in the EU don t loose this property of being Registered. If a substance registered in the EU is exported outside of the EU and later re-imported into the EU, the substance does not require further Registration Traceability is important The substance MUST be the same i.e., blending formulation is fine, synthesis is NOT An easy business case is buying a substance in the EU, blending it outside the EU with other substances and selling it to EU: EU Many more potential scenarios; important to get confirmation about registration 29

30 REACH REGISTRATION DEADLINES Substances Deadline Remarks Pre-registered phase-in substances: 1000 t/a 100 t/a & R50/53 1 t/a and CMR Pre-registered phase-in substances: 100 t/a Pre-registered phase-in substances: 1 t/a Non-phase in substances 1 t/a November 11, May 31, May 31, Prior to manufacture or import Registration must be submitted ONLY following INQUIRY to ECHA 30

31 REACH REGISTRATION - PROCESS For substances manufactured / imported in EU in amount 1 tpa Step 1 Pre-registration (for phase-in substances) (NO LONGER AVAILABLE since May 31, 2017) Inquiry (for NON phase-in substances) Step 2 Registration, including: SIEF (Substance Exchange Forum) communication; Lead registrant / co- registrant dossier preparation; Chemical Safety Report preparation REACH Regulatory Overview, M. Corazza, April

32 REACH REGISTRATION SIEF COMMUNICATION Governed by OSOR principle: ONE SUBSTANCE ONE REGISTRATION Connection between registrants of the same substance for dossier creation to: Define involvement of each SIEF member; Propose a Lead Registrant and request agreement; Define substance identity; Share data available to SIEF members; Inform on project plan, progresses & joint submission date; Inform on predicted cost; Inform about CLP classification once defined; Provide Letter of Access to co-registrants; Follow up beyond submission. REACH Regulatory Overview, M. Corazza, April

33 REACH REGISTRATION DATA REQUIREMENTS Data requirements are dependent on tonnage band: Annual Tonnage Annex 1 10 tpa REACH Annex VII tpa REACH Annex VII & VIII and Chemical Safety Report (CSR) tpa REACH Annex VII, VIII & IX and CSR 1000 tpa REACH Annex VII, VIII, IX & X and CSR All substances require Annex VI, full analytical data, to prove substance identity, typically IR, UV-VIS, NMR, GC etc. Data requirements in higher Annex require development, submission and approval of a REACH testing proposal. Reduced requirements for isolated intermediates and transported intermediates if manufacture and used under Strictly Controlled Conditions (SCC). 33

34 REACH REGISTRATION DOSSIER ELEMENTS Registration is company specific and requires: For all Registrants Identity of registrant; Identification and composition of the substance; Analytics (full reports); Nature and content of by-products, impurities; Information on manufacture and use. For Lead Registrant Only Robust study summaries & proposal for testing; Classification and Labelling; Chemical Safety Report (> 10t/y); Chemical Safety Assessment (hazardous substances) Exposure Scenarios (hazardous substances) Guidance on safe use. REACH Regulatory Overview, M. Corazza, April

35 Authorization 35

36 REACH AUTHORIZATION - PROCESS Manufactures / Importers must submit an authorization dossier for identified substances to maintain them on the market independently from their volumes (no 1tpa threshold). Phases: Authorities: identification of substances for the Candidate List (Substances of Very High Concern); Authorities: inclusion of the substances in Candidate List; Authorities: prioritization of substances; Manufacturers / Importers: application for authorization for specific uses; Authorities: granting of authorization; Authorities: review of authorization. REACH Regulatory Overview, M. Corazza, April

37 REACH AUTHORIZATION SUBSTANCES OF VERY HIGH CONCERN (SVHC) CMR Substances Carcinogenic, mutagenic and toxic for reproduction, substances meeting the criteria for classification in category 1A and 1B (CLP) PBT and vpvb substances Persistent, bioaccumulative and toxic substances, and very persistent and very bioaccumulative substance in accordance with criteria in Annex XIII Substances of equivalent concern With scientific evidence of probable serious effects, e.g. endocrine disruption. REACH Regulatory Overview, M. Corazza, April

38 REACH AUTHORIZATION - OUTCOME Authorization is granted if: Risks are adequately controlled ; Socio-economic benefits outweigh risks; There are no technically and economically viable alternatives Result: Time limited and company specific authorization for specific uses of the substance; A downstream user may only use the substance for that specific use if an authorization is granted to an actor up his supply chain. Sunset Date: The date from which placing on the market and the use of the substance is prohibited, unless an authorisation is granted for the use (placing on the market also means EU manufacture). REACH Regulatory Overview, M. Corazza, April

39 RESTRICTION 39

40 REACH RESTRICTION Limit or ban the manufacture, placing on the market or use of certain substances that pose an unacceptable risk to human health and the environment; Replace Directive 76/769/EC but same concept; Independent from tonnage (no 1tpa threshold); A Member State, or ECHA on request of the European Commission, can propose restrictions; List of restrictions consolidated in Annex XVII of REACH, including conditions; Restrictions refer to substances as such, in mixtures or in articles. REACH Regulatory Overview, M. Corazza, April

41 04 ARTICLES UNDER REACH

42 IMPORT OF ARTICLES Manufacture in Canada Export YES NO Canadian EU NO local YES Substance YES (Pre) registration / Inquiry / Registration NO Preparation YES (Pre)registration/ Inquiry/ Registration NO Article YES (Pre) Registration / Inquiry / Registration or Notification

43 SUBSTANCES IN ARTICLES Importers of articles need to register/notify a substance in the article: i. If the substance is intended to be released during normal and reasonable foreseeable conditions of use ii. Registration If there is substance above 0.1% in the article that is a Substance of Very High Concern (SVHC) listed on the Candidate List Notification (not necessary if exposure during normal and reasonable foreseeable conditions of use including disposal can be excluded) Communication (please note, no 1 t/a volume trigger) enough information to allow the safe use of the article to the recipients of the article iii. If the Agency requires registration because they suspect that there is release and risk AND if the total quantity of this substance present in these relevant articles is above 1 t/a per importer

44 IMPORTED ARTICLE Substance present > 1 tonne/year Unintentional release Intentional release Non SVHC SVHC present > 0.1% w/w Registration Exempt Notification to Agency

45 SUBSTANCES OF VERY HIGH CONCERN (SVHC) CMR Category 1 or 2 PBT/ vpvb Endocrine Disruptors Substances of Equivalent Concern List of SVHC s is available on ECHA website Known as Candidate List Updated on a regular basis (usually in June and December each year) SVHC s are candidates for Authorization Annex XIV substances are pulled from Candidate List

46 IMPORTED ARTICLE Registration Check components Check total volume Total quantity > 1 tonne + Intended to be released

47 IMPORTED ARTICLE Notification Check components Check total volume SVHC + Total quantity > 1 tonne + Presence > 0.1% w/w

48 05 NON-EU TO EU REACH SUPPLY CHAIN EXAMPLES

49 EXAMPLE Non-EU Manufacturer Manufactures substance A outside of the EU Sells substance A to the EU and outside the EU Appoints an Only Representative to cover substance A volumes sold to the EU Only Representative Appointed by Non-EU Manufacturer Acts as EU importer and fulfills registration obligations of substance A, maintains records (i.e. EU importers and volumes) Non-EU Formulator Purchases substance A from Non-EU Manufacturer and blends own mixutre Sells mixture (containing substance A) to the EU directly and to Non-EU Distributor REACH Supply Chain Coverage, Laurie Deleavey, May

50 NON-EU TO EU REACH SUPPLY CHAIN Non-EU Distributor Purchases mixture (containing substance A) from Non-EU Formulator and sells to EU CANNOT appoint an Only Representative in the EU EU Importers Imports substance A and mixture (containing substance A) from the non-eu manufacturer, formulator and distributor Must complete registration of imported substances where no OR has been appointed EU Downstream Users Downstream Users A, B, C, and D REACH Supply Chain Coverage, Laurie Deleavey, May

51 NON-EU REACH SUPPLY CHAIN COVERAGE For REACH registration, non-eu companies may: 1. Appoint an Only Representative (OR), where applicable) to complete registration; 2. Obtain coverage via an upstream supplier s OR who has registered the same substance; or 3. Leave it to the EU importer to take on responsibilities. 51

52 REQUIREMENTS FOR COMPLETE OR COVERAGE As per Article 8 of REACH, as part of his duties, the OR: shall keep available and up-to-date information on quantities imported and customers sold to 01 Substance covered must be identical to the substance supplied/registered 02 Supplier must agree to cover volumes of his specific substance 03 All EU importers of supplier s substance must be identified to the supplier s OR 04 Annual reporting of EU volumes (including any new EU importers) to supplier s OR is required REACH Supply Chain Coverage, Laurie Deleavey, May

53 REQUIREMENTS FOR COMPLETE OR COVERAGE An agreement between Non-EU Formulator and Non-EU Manufacturer to cover: Annual volumes of substance A (in Non-EU Formulators mixture) Non-EU Formulator EU importers Non-E Manufacturer must ensure the registered tonnage band reflects total volume covered by his OR Non-EU Formulator may submit required information either to the: 1. Non-EU Manufacturer to submit to their OR; OR 2. OR of the Non-EU Manufacturer directly Non-EU Manufacturer s OR shall provide Non-EU Formulator with: 1. Notification letter to provide to the EU importer(s) 2. REACH Verification Certificate for substance A can also be obtained REACH Supply Chain Coverage, Laurie Deleavey, May

54 06 DEVELOPING A REACH STRATEGY

55 CHEMICAL RESPONSIBILITIES ASSESSMENT A chemical responsibilities assessment should be completed as the initial step to feed into the development of a pre-registration strategy and identify recommended actions to be taken to ensure uninterrupted business in the European Community without infringing upon the REACH Regulation 1. Categorize Products By Type Substance, mixture, article 2. Determine your REACH company status (i.e., manufacturer, formulator, importer, downstream user, toller) Assess supply chain for legal REACH Importer Note formulation aspects for distributors and trading companies Toll manufacturers are considered to be manufacturer for the purposes of REACH and are required to register the substance manufactured. 3. Determine your REACH requirements based on: Product category Company status Your role in supply chain Upstream supply chain support

56 CHEMICAL RESPONSIBILITIES ASSESSMENT (CON T) 4. For each substance shipped into (or manufactured in) the EU at a level near or above one tonne, those on the Candidate List (SVHC), as well as substances restricted by REACH Annex XVII, identify and justify Phase-in status Late Pre-registration applicability Registration requirement and deadline (if pre-registration in place) SVHC status REACH Annex XVII Restriction status 5. Identify applicable registration options Upstream supplier, Customer, Only Representation 6. Determine dates/deadlines for product responsibilities Assess long-term requirements such as Authorization

57 JOINT REGISTRATION Create a Registration Roadmap that identifies: Prescribed analytical tests required for each substance joint registration dossier Including legal text requirements and Consortium recommendations SIEF Registration status Consortium identity Lead Registrant identity Letter of Access cost * Letter of Access information Substance ID / Sameness profile Uses covered by Lead Registrant Chemical Safety Report ECHA REACH Registration fee Estimated timeline for Inquiry / Registration Check Substance Sameness Gather substance identity information Compare substance identity to Consortium/SIEF/ECHA identity requirements Analyze differences and assess corrective actions

58 JOINT REGISTRATION (CON T) Determine further analytical testing requirements Assess analytical data to verify: IUCLID, Consurtium, SIEF, ECHA requirements Review for acceptance according to ECHA rules Further analytical tests may be required (budget for costs) Substance identification data, sameness testing required for Inquiry dossiers and joint registration dossiers. Verify that uses and Exposure Scenarios are covered by the Lead Registrant dossier Identify additional processes required where these are not covered by the Lead Registrant dossier May need to carry out your own chemical safety assessment and prepare your own downstream user chemical safety report Prepare additional uses for the Chemical Safety Report if Client uses are not included in Lead Registrant dossier Create Joint Registration dossier in IUCLID and submit via Only Representative

59 07 REACH HURDLES AND LEARNING

60 REACH REGISTRATION - HURDLES SIEF communication is often slow, especially when the substance is not registered yet; Agreeing on a substance identity profile often requires sharing of detailed knowledge about the production process (confidential business information); Slow SIEF communication results in time constraints for registrants (Lead Registrant and coregistrants); If Lead Registration is required the complexity of a REACH project results in timelines of greater than one year; Timelines for testing are extensive and grow longer as the REACH 2018 deadline approaches; Keep in mind the sameness testing requirements even if you are only a co-registrant. Tools are continuously changed / updated by ECHA (Guidance documents, IUCLID, CHESAR, REACH- IT) REACH Regulatory Overview, M. Corazza, April

61 REACH REGISTRATION - LEARNINGS Many projects started late due to long decision making process within SIEFS and within companies; Collecting or preparing suitable analytical data can be a slow process, especially for UVCB substances and monomers imported as polymers; Process to acquire Letter of Access from Lead Registration requires several steps and can delay the co-registration process; Resources need to be dedicated to registration activities even if the technical work is subcontracted; Significant efficiency benefits can be recognized by working on several substances at the same time Substances with same use patterns; or Substances having similar structural elements. If (late) pre-registration has not been completed, and Inquiry is now required prior to registration Always checked by ECHA, typically 4-6 weeks for response During the inquiry phase and until registration dossier is complete, submitted and accepted, manufacturing and importing is restricted to <1 tpa. PLAN AHEAD. REACH Regulatory Overview, M. Corazza, April

62 Joyce Borkhoff, Vice President, Chemicals Group Intertek Scientific & Regulatory Consultancy intertek.com/green/chemicals/

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