Services

One of the key aims of REACH is to gain information about the properties of substances that are manufactured, supplied and used in the EU. However, the body of information must be collated using the minimum number of animal tests. This means that, in some circumstances, it is mandatory to inquire from ECHA whether a registration has previously been submitted for the same substance:

  • Potential registrations of non-phase-in substances.

  • Update of an existing registration because of a tonnage band increase.

 

To allow ECHA to decide whether a substance is a new or previously registered chemical, the inquiry dossier must contain appropriate and adequate substance characterisation data. The outcome of the inquiry will reveal whether the same substance has been previously registered and whether it is applicable to release details of pre-existing tests. This is particularly important when study reports describing animal investigations are owned by other registrants and data must be shared.

Our team can complete as many of the steps involved in the Duty to Inquire process as required:

  • Review substance details and tonnage information to ensure compliance with the REACH Regulation.

  • Create a REACH-IT account with ECHA on behalf of the client.

  • Submit the Duty to Inquire dossier.

  • Provide the client with their company-specific inquiry number and details of other registrants.

  • Advise on the obligations following the inquiry process (such as data requirements for the REACH registration dossier and work flow).

  • Arrow Regulatory Limited can be named as a Third Party Representative and act on behalf of the client. This can be for reasons of commercial confidentiality or to provide expertise in data sharing negotiations. However, the client has full control of any subsequent registration and retains legal responsibility.

  • We also provide an Only Representative service for non-EU companies wishing to enter the EU market. Click here.

 

Arrow Regulatory Limited have substantial experience in submission of Article 26 dossiers and are able to provide practical assistance throughout the inquiry and any subsequent registration process.

REACH encourages initial and subsequent scientific innovation by recognising the concept of Product and Process Orientated Research and Development (PPORD). This means that once PPORD status is obtained, substances under development are exempt from REACH registration for a period of 5 years. The PPORD status can also be renewed for a further 5 years.

 

Arrow Regulatory Limited are able to ensure correct presentation of information within the PPORD notification that must be submitted to ECHA:

  • Identity of the manufacturer or importer.

  • Identity of the substance.

  • Classification of the substance.

  • Estimated quantities.

  • List of customers (including names and addresses).

 

Our team is familiar with the tasks involved with submitting a successful PPORD notification and we are able to complete as many of the steps as the client finds helpful. In a typical project the Arrow Regulatory experts will:

  • Advise on whether the proposed activity falls within the scope of PPORD.

  • Assist with authoring of the justification for PPORD status.

  • Discuss substance identification methods and suggest suitable testing houses.

  • Provide guidance on classification and labelling.

  • Put in place legal entities for the PPORD notifier and their customers using ECHA’s REACH-IT system.

  • Create reference substances to describe the material that is the subject of the PPORD.

  • Produce the substance dataset for the PPORD notification using IUCLID and generate the final dossier.

  • Export the PPORD dossier in the expected electronic format and submit the dossier to ECHA via REACH-IT.

  • Provide the notification number supplied by ECHA after the technical completeness check is complete and the PPORD fee has been received.

  • Advise on any questions raised by ECHA after submission of the PPORD dossier.

  • Update and/or re-submit the PPORD notification as scientific development proceeds and the client’s customer base expands.

Arrow Regulatory Limited

6th Floor, City Gate East

Toll House Hill

Nottingham NG1 5FS

UNITED KINGDOM
 

T: +44 (0) 115 9352243

Arrow Regulatory (Ireland) Limited

9 Pembroke Street Upper
Dublin 2

D02 KR83

IRELAND


T:  +353 (0) 1 653 2165

Arrow Regulatory GmbH

Grabenweg 68

6020 Innsbruck

Tirol

AUSTRIA


T:  +43 (0) 660 1162392   

© 2020 Arrow Regulatory

Arrow Regulatory Limited is a company registered in England and Wales with company number 10171397. Registered Office: 149-155 Canal Street, Nottingham,  NG1 7HR, UK

Arrow Regulatory (Ireland) Limited is a company registered in Ireland with company number 614017. Registered Office: The Black Church, St Mary's Place, Dublin 7, D07 P4AX, Ireland

Arrow Regulatory GmbH is a company registered in Austria with a company number FN 529749. Registered Office: Grabenweg 68, 6020 Innsbruck, Tirol, Austria