SIEFs > Legal obligations in SIEFS

What are legal obligations ?

Specific provisions on SIEFs can be found in Article 29 of REACH Regulation (SIEF Formation), other references are made in Article 11 (Joint Submission) as well as in Articles 25.1,25.2 and 29.3 (Data sharing obligations).

All SIEF Participants shall:

  • React to requests for information from other participants,
  • Provide other participants with the existing studies upon request.

Potential Registrants shall:

  • Request missing information needed for their registration dossiers from other SIEF participants,
  • Collectively identify needs for further studies to comply with registration requirements,
  • Make arrangements to perform the identified studies,
  • Agree on classification and labelling.

Data holders, a Data Holder is any person holding information/data relevant to a phase-in substance and willing to share the data, within a SIEF. They:

  • Must respond to any query from potential registrants if they hold the data relating to this query,
  • Are not entitled to request data.

SIEF shall remain operational until june 2018. The data sharing in a SIEF must lead to a single joint submission for each substance, thereby avoiding unnecessary animal testing and cost. participants in a SIEF are free to organize themselves in Consortia or other forms of agreements as they see fit to carry out their obligations under REACH.