Supporting a major flavouring manufacturer and supplier with all aspects of their 2018 REACH registration obligations

Client

A global company manufacturing and supplying a large portfolio of flavouring and fragrance substances.

Background

EU manufacturers or importers of substances at tonnages of 1-10 and 10-100 per annum are required, under the REACH regulation, to submit a registration dossier of information on each of their substances by the end of May 2018. The required dossiers includes data relating to the use, physico-chemical properties, environmental fate and behaviour, and (eco)toxicology of their substances. REACH registration is complex and resource intensive.

Project goals

To support the client with all aspects of their 2018 REACH registration obligations, from project management responsibilities to development and submission of the full technical dossiers required for successful registration (as lead or member).

Approach

Bibra is currently assisting the client with a large number of REACH registration dossiers for the 2018 deadline in a pragmatic, timely and cost-efficient manner. We are involved in all aspects of the registration process including identification of relevant information, data mining, assessment of the reliability and quality of the published and unpublished dataset, extensive data-gap analyses, use of read-across, weight-of-evidence and (Q)SAR, advising on appropriate Integrated Testing Strategies, study commissioning and monitoring (where needed), preparation of (Robust) Study Summaries and associated endpoint summaries, completeness checks, classification and labelling, preparation of CSRs (including calculation of DN(M)ELs, PNECs, related RCRs, and PBT/vPvB assessments). Bibra also provides IUCLID web-hosting to the client.

Bibra project leaders

Richard Young

REACH Regulation and Compliance

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