Substance registration services

Substances manufactured in or imported into Europe in quantities greater than one ton per year must be registered under REACH with few exceptions, even when they are merely imported as part of a finished cosmetic product. REACH registrations are a complex process that BIORIUS can manage for you, including the monitoring of experimental studies. The detailed requirements for registration are dependent on the tonnage. There are two possible situations: the substance has previously been registered by another company or no previous registration exists (and would require a different level of investment).

Generic services:

  • Only representative: Only European legal entities can conduct a registration under REACH. A natural or legal person established outside the EU can appoint an only representative to carry out the registration of the substance exported (as such, in a mixture or in an article) into the EU (Article 8(1)). As a result, its European clients who import their products will then be relieved of REACH registration obligations.
    BIORIUS can assume the role of your “Only representative” if you are a non-EU company exporting substances that are required to be registered.
  • Inquiry: The first step for any registration is an inquiry. Inquiries require analytical documentation that can be difficult to obtain. BIORIUS can contact your supplier to obtain the appropriate documentation and/or conduct the necessary chemical analysis in addition to carrying out the inquiries on REACH-IT.

Services for substances previously registered:

If you plan to register a substance for which a REACH dossier has already been submitted, the SIEF/Consortium must be contacted, and access to the dossier must be negotiated. In addition, certain parts of the dossier are under the responsibility of each individual registrant.

BIORIUS can manage the entire process, including the following steps:

  • Contacting the lead registrant and/or SIEF or consortium manager
  • Evaluating the dossier quality
  • Negotiating the cost of access to a joint submission
  • Creation of an IUCLID file and filing of the individually submitted information
  • If necessary, performing the Chemical Safety Assessment (CSA) and writing the Chemical Safety Report (CSR)
  • Dossier Submission

Services for new dossiers:

If the substance has never been registered, a complete dossier must be generated, including the conducting of any necessary experimental toxicological studies. However, in the case of substances imported only as finished cosmetic products, specific exemptions  may be applicable.

BIORIUS can manage the entire process, including the following steps:

  • SIEF Management
  • Creation of a specific testing strategy
  • Monitoring experimental studies performed in high-quality CRO laboratories. In the specific case of cosmetic substances, priority will be given to In Silico (or read-across) and In Vitro studies, including:
    • Physicochemical studies
    • Human health studies
    • Environmental fate studies
    • Ecotoxicological studies
  • Creation and filling of an IUCLID file
  • If necessary, conducting the Chemical Safety Assessment (CSA) and writing the Chemical Safety Report (CSR)
  • Dossier Submission

Post-registration services for existing dossiers:

REACH registration work does not end with the submission of a dossier. We also provide services for your previously-submitted dossiers, even if we weren’t part of the initial submission. Such services include:

  • SIEF management
  • Tonnage updates
  • Usage updates
  • Testing proposal follow-up
  • Compliance checks management
    • Communication with ECHA and MS
    • Test monitoring
  • CORAP management
    • Communication with ECHA and MS
    • Test monitoring
  • Participation in comments for other REACH processes
    • Harmonized classification
    • Restriction
    • Authorization
    • RMOA

Any questions?

Contact

Rue Joseph Wauters, 113
7170 Manage, Belgium

+32 2 888 40 10
+44 20 3866 1208

info@biorius.com

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