ATOUT REACH – Presentation, skills and services

Reach

ATOUT REACH is working with worldwide companies, especially as Only Representative (OR) in REACH for non-European manufacturers and as Representative in the Biocides Regulation framework. We also participate to international conferences and regulatory events: this could help us to meet each other, then please feel free to contact us!

Who we are? 

ATOUT REACH (GICPER legal entity) is an associative consultant:

  • Supported by the French chemical industry federation (UIC) since 10 years, thanks to the expertise of the 10 experts who developed this activity
  • The objective is to draw on our expertise in the implementation of chemical regulations, to provide a personalized service based on listening, analyzing the context and putting the issues into perspective
  • ATOUT REACH ensures that you have the cards in hand to decide the most appropriate solution and sustainably meet your regulatory obligations and make your regulatory compliance an asset

Our skills on regulatory environment

 We manage Chemical regulations, aiming to provide best expertise on every topic and ensure technical dossier compliance.

  • Regulations:
    • REACH
    • CLP
    • Biocides
    • Other: cosmetics, health and safety at work with chemicals…
  • Expertises:
    • Chemistry
    • tox/ecotox
    • Hygiene, Safety and Environnement
  • Implementations:
    • Softwares use trainings: IUCLID 6, REACH IT, CHESAR, R4BP, SPC Editor…
    • Type of services:
      • Regulatory compliance: registration REACH, OR, authorization Biocide, audit...
      • Defense of your interests: strategic advice, costs / data sharing…
      • Trainings: intra / inter-company
      • Helpdesk

Cartography of our services about REACH and Biocides

Apart from trainings we propose on all these regulations and associated softwares, our services are the following:

 

 

REACH/FDS/CLP

Registration

  • Registration strategy tips
  • Elaboration of registration dossier (joint and as member) and of the chemical Safety Report (CSR)
  • Only Representative (OR)
  • Letter of Access (LoA) cost calculation and management

Communication in the supply chain

  • Création, audit and update of extended eFDS / FDS
  • Classifications of substances & mixtures
  • Adequacy with exposure scenario, sector use maps
  • Elaboration of exposure scenario/  risk assessment in case of specific uses

Traceability of SVHC (Substances of Very High Concern)

  • Collection of data from suppliers on the presence of SVHC to more than 0.1% in articles.
  • Monitoring and alerts on articles impacted by SVHC

On-site diagnostics, inspection preparation audits, etc.

 
 

 

 

BIOCIDES

Strategy

  • Marketing: regulatory cost, budget, deadlines and deadlines, consortia
  • Development of a Family of Biocidal Products

Compliance of active substances (AS)

  • AS approval / Letters of Access acquisition
  • Expertise on in-situ generation
  • Compliance of biocidal products
  • Authorization file

Preliminary risk assessment

  • Supporting product development
  • In the context of applications for approval / authorization
  • Writing in standardized format "PAR“

Miscellaneous

  • Approved suppliers complianceüLabeling validation
  • Compilation under IUCLID, Summary of Product Characteristics (SPC)
  • Expertise on efficacy
 

Focus on REACH Only Representative services

ATOUT REACH is an active Only Representative, working with various non-European companies worldwide. Our experts speak fluent english and are experimented in REACH Only Représentaive dossiers handling and registration. ATOUT REACH is member of the Only Representative Organization (ORO), then we ensure best practices and robust compliance, as well as ”tailor-made” services for our clients. 

The OR missions 1 and 2 presented below allow to ensure your direct compliance as well as define a long-term strategy to secure your importations in Europe. Optional missions n°3 and 4 are also proposed to help you managing this issue and assist you on REACH regulation, in case of need.

Missions Follow-up detail
N°1

Only Representative responsibility and project management:

  • OR agreement negotiation
  • Certificates for REACH compliance and OR designation
  • Pre-registration and Legal Entity creation/transfer in REACH-IT
  • Data transfer organisation and reporting
  • Long-term REACH compliance strategy
N°2

Costs for reach compliance related missions:

  • Safety Data Sheet (SDS) ans extended SDS writing/updating/checking (English or French)
  • Classification and Labelling (C&L)notification to ECHA
N°3

Extended communication with importers

  • Identification & contact,
  • Collect of exposure scenarios of Downstream User (DU), communication of Safety Data Sheet (SDS) and follow-up any changes in uses and organize appropriate actions
  • Monitor supply patterns from volumes of imports (substances and/or mixtures) for each importation
N°4

Assistance ticket in case of the Client's questions

  • Helpdesk on REACH, CLP or other regulatory purposes
  • Question asked to ATOUT REACH who communicates time needed for answering, validated by the client  prior completion

Please contact us for detail of our services: info@atoutreach.fr

Focus on REACH SIEF management and Letter of Access handling

In order to comply with REACH, Lead Registrants have to organise cost and data sharing among Substance Information Exchange Forums (SIEF) members. In particular, REACH article 27 organises the data sharing process, as follows:

-      27(1) – potential registrant is to request information from previous registrant(s);

-      27(2) – obligation to make every effort to reach agreement for both parties;

-      27(3) – obligation to make every effort to share costs in a fair, transparent and non discriminatory way;

-      27(4) – communication between previous and potential registrants of information in case of agreement;

The implementing regulation on data sharing n°2016/9 enforced this process under REACH precising the refunding mecanisms and the “one substance one registration” OSOR principle.

ATOUT REACH proposes to accompany your enterprise in data and cost sharing to preapre Letters of Acess (LoA), share costs of your registration fulfilling the obligations as Lead Registrant under REACH.

Project steps Detail
Step 1: Preparation of cost/data sharing material
  • Drafting of SIEF agreement (and/or consortium agreement, cooperation agreement) and Letter of Access based on Cefic model, validation by the Lead Registrant
  • Pre-SIEF survey to identify interested entities
  • Letter of Access (LoA) cost calculation: listing and valuation of the studies and their reliability, cost sharing rules and breakdown (based on annex III of Cefic’s SIEF Agreement template)
  • Learning  and validation of cost/data sharing by the Lead Registrant
Step 2 : Communication with pre-SIEF members
  • Communication to present data and cost sharing conditions to all pre-SIEF members
  • Sending of SIEF agreement (and/or consortium agreement, cooperation agreement), listing and valuation of the studies as well as cost breakdown upon request of interested pre-SIEF members
  • Answer to pre-SIEF members questions on registration and sharing
Step 3 : Contracts and LoA management

Coordination of the following tasks between the pre-SIEF member and the Lead Registrant:

  • signature of SIEF agreement (and/or consortium agreement, cooperation agreement, 2 hard copies)
  • invoicing, payment and signature of Letter of Access costs (1 hard copy)
  • Generation and sending of Join Submission package (token and Join Submission name, and eventually Chemical Safety Report, IUCLID reference substance…)
Step 4 : SIEF follow-up
  • Follow up of SIEF evolution and refunding with the Lead Registrant (once yearly) until 31 May 2020
  • Answers to SIEF members upon requests until 31 May 2020

Optional data sharing processes are described in REACH article 27 and organised as follows:

-      27(5) – communication with ECHA in case of failure to reach an agreement;

-      27(6) – decision of ECHA on whether to give permission to the potential registrant to refer to the information submitted by the previous registrant in his registration dossier;

-      27(7) – potential appeal against an ECHA decision under Article 27(6);

-      27(8) – extension by four months of the waiting period, upon request by the previous registrant (Art. 27(4) and 27(6)).

Cases of dispute with ECHA's Board of Appeal are not often met, but ATOUT REACH is experienced in LoA handling and can advise you in this process as well.

Please feel free to contact us!

Our english-speaking experts will be happy to answer your demands: you can contact us by email (@ : info@atoutreach.fr) or by phone: (office : +33 146 531 120).

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