REACH compliance Services
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Highlights on REACH
Regulation Links
EU REACH : Regulation (EC) No 1907/2006 & Subsequent amendments [V_28.04.2020]
Brief Summary
Regulation (EC) No 1906/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) was adopted late 2006 and entered into force on 1 June 2007, aiming to improve the protection of human health and the environment from the risks that can be posed by chemicals, while enhancing the competitiveness of the EU chemicals industry.
REACH establishes procedures for collecting and assessing information on the properties and hazards of substances.
REACH requires that all chemical substances placed on the European market in quantities equal or above 1 tonne per year shall be registered to the European Chemicals Agency (ECHA) before their placing on the market.
All EU manufacturers and importers of chemical substances have to comply with REACH.
Authorities can either ban hazardous substances should risks related to the manufacturing or uses, be unmanageable, or decide to restrict a use or make it subject to a prior authorisation procedure.
Terminology under REACH
Substance :
Means 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.
Mixture :
Means a mixture or solution composed of two or more substances.
Supplier of a substance or a mixture :
Means any manufacturer, importer, downstream user or distributor placing on the market a substance, on its own or in a mixture, or a mixture.
Manufacturer :
Means any natural or legal person established within the Community who manufactures a substance within the Community.
Importer :
Means any natural or legal person established within the Community who is responsible for import.
Registrant :
Means the manufacturer or the importer of a substance or the producer or importer of an article submitting a registration for a substance.
Use :
Means any processing, formulation, consumption, storage, keeping, treatment, filling into containers, transfer from one container to another, mixing, production of an article or any other utilisation.
Only Representative - Article [8] :
A natural or legal person established outside the Community who manufactures a substance on its own, in mixtures or in articles, formulates a mixture 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.
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 proceedings 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.
More definitions ...
Link: REACH definitions.
Our Regulatory Services on REACH
Service 01: REACH assessment on Chemicals and Mixtures
- ¤ Identify REACH compliance requirements for all stakeholders (The entire supply chain, including EU importers and regional plants).
- ¤ Identify, review, all products put on the market. Determine the regulatory status of these products, whether they fall fully or partially under REACH.
- ¤ Identification of the registrant entities (who must legally undertake the registration process)".
- ¤ Recommendations regarding the adequate REACH Compliance Process Management.
- ¤ Evaluate if applicable, the pros and cons of the different registration schemes (joint registration process (OSOR) versus independent registration process ¤ confidentiality -). The registration involves “substances” and not “products” as a whole.
- ¤ Define if applicable, a roadmap for the months to come for substances registration or exemption process including costs estimates based on the identified substances and projected sales/import volumes.
Service 02: Acting as REACH Legal Representative (OR, TPR)
- ¤ Acting as a legal REACH Only Representative (OR) for non-EU manufacturers, in accordance with Article 8 of REACH Regulation.
- ¤ Or, acting as a legal REACH Third Party Representative (TPR) for EU manufacturers and importers, in accordance with Article 4 of REACH Regulation.
- ¤ Generation and transmission of REACH compliance documents, including:
- • REACH Representative appointment statement
- • Issuing of REACH Registration certificates
- • Issuing of REACH tonnage coverage certificates
Service 03: Supply Chain Management
- ¤ Instant online REACH verifications for actors in the supply chain.
- ¤ Checking the validity of any provided registration number.
- ¤ Communication and Assistance to EU importers, Downstream Users or Upstream suppliers.
- ¤ Verification of supplier’s compliance levels.
- ¤ REACH Compliance documents (REACH certificates, SDS, etc.) transmission upon request to supply chain actors and Authorities.
Service 04: Legal Administrative Changes Process
- ¤ The Only Representative (OR) change (substitution) procedure.
- ¤ The Third Party Representative (TPR) change (substitution) procedure.
- ¤ Duties related to modifications of legal entity identity, with regard to existing compliance assets.
- ¤ Reporting legal changes to the registration body (ECHA).
- ¤ Note:
- • We offer a specific service-portfolio in matters of BREXIT.
- • In short, UK companies are required to appoint EU based Only Representatives, and proceed to the transfer of all ECHA issued registrations to those EU entities.
Service 05: REACH Registration as Lead Registrant
- ¤ Initial REACH Assessments
- • Preliminary regulatory assessments on chemicals (identification, sameness, etc.)
- ¤ REACH Registration
- • Inquiry-dossier Generation and Submission
- • SIEF formation, and Lead Registrant election
- • Identification of Data Gap and Waiving
- • REACH Testing
- • Data Sharing cost calculations
- • Lead Registrant (joint submission) Dossier Generation, and Submission
- • Generation of Chemical Safety Assessments (CSA), and Chemical Safety Reports (CSR)
- • Generation of Exposure Scenario (ES)
- • CBI Protection
- ¤ REACH Post Registration
- • Communication with EU Authorities in case a Dossier Evaluation step is required
- • Appeal against ECHA decisions
- • Updating of post Registration Dossiers
- • Joint Submission Management (Open communication channel with late potential Registrants; Managing the selling of the Letter of Access (LoA), on behalf of the client; Issuing of Token information, etc.)
- ¤ Extending valued Data Sharing assets on behalf of the client
- • Communication links with other potential Data recipients (byers) in foreign countries, i.e. : China, South Korea, Japan, Turkey, USA, Canada, etc.
Service 06: REACH Registration as Active Member
- ¤ Preliminary regulatory assessments on chemicals (identification, sameness, etc.)
- ¤ Inquiry-dossiers generation and submission
- ¤ SIEF participations
- ¤ LoA purchasing on behalf of the client
- ¤ Generation of the Technical Dossiers under IUCLID-X
- ¤ REACH Dossier Submissions
- ¤ CBI Protection
Service 07: REACH Testing Assessment
- ¤ Collect of existing data
- ¤ Identification of data gap
- ¤ Determination for testing / waiving conditions
- ¤ Planning and supervision of GLP certified testing
- ¤ Testing report review and validation
Service 08: Analytical Testing
- ¤ Analysis for organic substances
- • Ultra-violet spectrum
- • Infra-red spectrum
- • Nuclear magnetic resonance (NMR) spectrum
- • Mass spectrum
- • High-pressure liquid or gas chromatogram
- • And generally: XRD, and / or, ICP for inorganic substances
- ¤ Note:
- • Analytical data is required for all registration dossiers, for proving to ECHA basis for substance identity sameness, in relation to the Lead Registrant ‘s SIP (Substance Information Profile).
Service 09: Substance Safety Data Sheets (SDS/MSDS/eSDS) Authoring
- ¤ Express Authoring services for
- • SDS
- • MSDS
- • eSDS
- ¤ Notes:
- • Service details are thoroughly presented in the SDS/MSDS/eSDS authoring section.
Service 10: SVHC and Authorisation Process
- ¤ Management of SVHC
- • SVHC testing
- • SVHC certificate issuing
- • SVHC Candidate-list continuous monitoring
- • SVHCs screening and substitutions
- ¤ REACH Authorisation process
- • Screening substances against Annex XIV, substitutions assessment
- • Authorisation dossier generation and submission, for each identified use
- ¤ Note:
- • When a Substance of Very High Concern (SVHC ) is listed in Annex XIV of REACH, the Authorisation process is required, as opposed, to the Registration process.
Service 11: REACH Restriction Process
- ¤ Screening substances against Annex XVII
- ¤ RoHS testing
- ¤ SVHC testing
Service 12: Disputes Resolutions
- ¤ Reviewing and submitting claims to ECHA
- ¤ Appeals against certain decisions of the Chemicals Agency
- ¤ In the last resort, instituting legal proceedings against unjustified LoA costs from Lead Registrants
Service 13: SCIP Notifications
- ¤ SCIP Notifications
- • Starting on 05 January 2021, notifications of SVHCs contained in articles to the SCIP database is mandatory
- • This new notification scheme applies to companies placing articles containing SVHC > 0.1% on the EU market
When time is of the essence...
- Within the shortest possible delays
- With more than 10 years of experience in the régulatory industry, our services are provided speedy and effectively in accordance with the target legislations and rules of procédures; as well as the rules within that govern the handling of business confidential informations.