REACH Online
Call us now!
+44 870 8 200 310
Check out our new REACH compliance website! Get your SDS audited for free!
Write to a human
 
TITLE-III: DATA SHARING AND AVOIDANCE OF UNNECESSARY TESTING
CHAPTER-2: Rules for non-phase-in substances and registrants of phase-in substances who have not pre-registered
ARTICLE 27: Sharing of existing data in the case of registered substances
Lost in REACH? Not anymore! Try our new REACH Compliance Website
  • Assessment of REACH obligations
  • Letter of Access (LoA) negotiation
  • SDS authoring with 100% guarantee
  • REACH and CLP consulting
  • REACH Registration
  • REACH Compliance auditing
  • REACH Certificate and declaration
  • REACH Only Representative (ROR) services
ARTICLE 27: Sharing of existing data in the case of registered substances
1. Where a substance has previously been registered less than 12 years earlier as referred to in Article 26(3), the potential registrant:
(a) shall, in the case of information involving tests on vertebrate animals; and
(b) may, in the case of information not involving tests on vertebrate animals,
request from the previous registrant(s) the information he requires with respect to Article 10(a)(vi) and (vii) in order to register.
2. When a request for information has been made according to paragraph 1, the potential and the previous registrant(s) as referred to in paragraph 1 shall make every effort to reach an agreement on the sharing of the information requested by the potential registrant(s) with respect to Article 10(a)(vi) and (vii). Such an agreement may be replaced by submission of the matter to an arbitration board and acceptance of the arbitration order.
3. The previous registrant and potential registrant(s) shall make every effort to ensure that the costs of sharing the information are determined in a fair, transparent and non-discriminatory way. This may be facilitated by following cost sharing guidance based on those principles which is adopted by the Agency in accordance with Article 77(2)(g). Registrants are only required to share in the costs of information that they are required to submit to satisfy their registration requirements.
4. On agreement on the sharing of the information, the previous registrant shall make available to the new registrant the agreed information and shall give the new registrant the permission to refer to the previous registrant's full study report.
5. If there is failure to reach such an agreement, the potential registrant(s) shall inform the Agency and the previous registrant(s) thereof at the earliest one month after receipt, from the Agency, of the name and address of the previous registrant(s).
6. Within one month from the receipt of the information referred to in paragraph 5, the Agency shall give the potential registrant permission to refer to the information requested by him in his registration dossier, subject to the potential registrant providing, upon request by the Agency, proof that he has paid the previous registrant(s) for that information a share of cost incurred. The previous registrant(s) shall have a claim on the potential registrant for a proportionate share of the cost incurred by him. Calculation of the proportionate share may be facilitated by the guidance adopted by the Agency in accordance with Article 77(2)(g). Provided he makes the full study report available to the potential registrant, the previous registrant(s) shall have a claim on the potential registrant for an equal share of the cost incurred by him, which shall be enforceable in the national courts.
7. An appeal may be brought, in accordance with Articles 91, 92 and 93, against Agency decisions under paragraph 6 of this Article.
8. The registration waiting period in accordance with Article 21(1) for the new registrant shall be extended by a period of four months, if the previous registrant so requests.
Referred by:
ARTICLE 10: Information to be submitted for general registration purposes
ARTICLE 17: Registration of on-site isolated intermediates
ARTICLE 18: Registration of transported isolated intermediates
ARTICLE 21: Manufacturing and import of substances
ARTICLE 26: Duty to inquire prior to registration
ARTICLE 91: Decisions subject to appeal