Regulatory Tips

Strategies for Enforcement of REACH and CLP

Enforcement strategies identified and agreed upon initially by the Forum for Exchange of Information on Enforcement.

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Minimum Criteria for REACH and CLP Inspections

In order to enable the system introduced by REACH and CLP to operate effectively in practice, Member States are obliged to establish the necessary arrangements for its implementation and enforcement. One of the most important elements of the overall enforcement of both REACH and CLP is inspection.

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REACH Representative Services

Introduction to B-Lands Legal Representation Services

By law, and for accountability issues, a non-EU entity is not permitted to submit on its own pre-registration or registration dossiers to the European Chemicals Agency (ECHA).

Under REACH [Art.8], a natural or legal person established outside the EU, who manufactures a substance, formulates a mixture or produces an article can appoint an only representative to fulfil the obligations of importers and to carry out the required registration of the substance that is imported (as such, in a mixture or in an article) into the EU.

This relieves the EU importers within the same supply chain from their registration obligations, as they will be regarded as downstream users.

Additionaly, potential registrants may retain [Art.4] the service of a third party representative to shield their identity from other co-registrants in the same SIEF, and through the data & cost sharing process.

Our Only Representative (OR) Service

The EU based legal entity, acting as the Only Representative, is to assume all obligations incumbent to REACH registrants and is liable (heavy fines, prison terms) under EU laws for any breach of this regulation.

Our Only Representative service covers the following responsabilities:

• REACH Technical Procedures

  • Substance inventory.
  • Substance pre-registration.
  • Substance registration.
  • Substance notification.
  • Substance authorisation.
  • Updating of the registration data (post registration duty).
• REACH Administrative Obligations
  • Legally responsible for meeting REACH compliance requirements on behalf of the client.
  • Communications with ECHA, and the national authorities, in relation with the on going compliance procedures.
  • Protection of the client Confidential Business Information (CBI).
  • Transmission of the information required under REACH, down and up the supply chain [Articles 31 - 34].
  • Meeting legal requirements for the archival and the quick retrieval of the substance information required under REACH, for a period of 10 years after the products last placing on the EU market [Article 36] (in case of accidental exposure, poisoning, etc.
  • Transmission of compliance supporting documents to the client's EU customers, EU authorities, and to EU customs when required for goods entering the EC customs territory.
• REACH Regulatory Services
  • REACH helpdesk support (Answering all client's inquiries on REACH).
  • REACH regulation monitoring (Alerts).

B-Lands Consulting Professional Liability Insurance:
AXA Insurance, Policy Number: 4878393004
Maximum Liability Coverage: 9 000 000 euros (Nine million euros)

Our New Client's Responsability:
To inform all EU importers in the same supply chain that he has appointed an only representative to conduct the registration thus relieving the importers from their registration obligations.

Getting in touch with our staff.

Taking over the Duty of a Former Only Representative

We offer a quick and effective OR transfert service, according to the legal framework established by the REACH authorities (ECHA) for such event.

A non-EU entity is allowed to change their only representative before the relevant registration deadline(s), or after the registration process is completed. This change will be handled in the REACH-IT system similar to a legal entity change.

The OR Transfert Service Involves:

  • Contacting the previous OR to organise the transfer and secure written proof of transfer of responsibility.
  • Creation of the new REACH-IT account.
  • CTransfert of the pre-registrations from the previous to the new account.

Documents that will be needed for implementing quickly the swicthing:

  • Individual letter(s)/contract(s) from the new Only Representative demonstrating that he/she has been appointed as only representative by the non-Community manufacturer under the REACH Regulation for the substance(s) in question.
  • Letter/contract from the previous only representative declaring that he/she will no longer act as an only representative and that he/she agrees to transfer his duties to the new only representative under the REACH Regulation for the relevant substance(s).

Getting in touch with our staff.

Acting as a Third Party Representative (TPR)

A third party representative can be appointed [Art. 4] by a EU manufacturer, EU importer or where relevant, EU downstream user, to allow this potential registrant, or data holder, to remain anonymous vis-à-vis other stakeholders (registrants, competitors) in the data sharing process.

Getting in touch with our staff.
Entry point for all regulatory services related to: REACH