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Retention periods REACH (1)

Retention periods REACH (1)

Summary dated April 15th, 2018 of the essential legal provisions regarding the retention periods of your archives.

Documents/Data Minimum retention period Format Start date of the retention period Act
Any data required to fulfil the obligations of a manufacturer (2)(4) 10 years In the framework of the obligation (3) As from the moment that the manufacturer has produced the substance or mixture concerned for the last time Art. 36, section 1 Regulation 1907/2006
Any data required to fulfil the obligations of an importer (2)(5) 10 years In the framework of the obligation (3) As from the moment that the importer has imported the substance or mixture concerned for the last time Art. 36, section 1 Regulation 1907/2006
Any data required to fulfil the obligations of a downstream user (2)(5) 10 years In the framework of the obligation (3) As from the moment that the importer has supplied the substance or mixture concerned for the last time Art. 36, section 1 Regulation 1907/2006
Any data required to fulfil the obligations of a distributor(2)(6) 10 years In the framework of the obligation (3)(6) As from the moment that the importer has used the substance or mixture concerned for the last time Art. 36, section 1 Regulation 1907/2006

Although we have composed this list with much care, Merak N.V. cannot be held responsible for any errors or any changes made to legislation.

(1) REACH is an acronym for “Registration, Evaluation, Authorisation and Restriction of Chemicals”. The key aspects of this regulation are set out in Regulation (EG) no. 1907/2006 of the European Parliament and the Council of December 18th, 2006 regarding the registration and evaluation of and the authorisation and restriction regarding chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Regulation (EEC) no. 793/93 of the Council and Regulation (EC) no. 1488/94 of the Committee as well as Directive 76/769/EEC of the Council and Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC of the Committee.
Within REACH, various groups of actors are distinguished: manufacturers, importers, distributors and downstream users. They each play a different role and have different obligations under REACH. The documents/data to be retained in the framework of REACH vary depending on the obligations to be fulfilled in the framework of this regulation. The following definitions are used when determining which role is played in the framework of REACH:

  • Manufacturer: a natural or legal person established in the European Union manufacturing a substance in the European Union;
  • Importer: a natural or legal person established in the European Union responsible for import;
  • Distributor: any natural or legal person established in the European Union, including retailers, who stores and sells a substance, as such or in a mixture, exclusively for and to third parties;
  • Downstream user: any natural or legal person established in the European Union, not being a manufacturer or importer, who uses a substance, as such or in a mixture, for his industrial or professional activities.
a natural or legal person established outside the European Union who manufactures a substance, as such, in preparations or articles, who formulates a preparation or manufactures an article imported into the European Union, is allowed to appoint, with joint approval, a natural or legal person established in the European Union to fulfil as his sole representative the obligations for importers under the REACH regulation.

(2) If the manufacturer (when registered), importer (when registered), downstream user or distributor ends his activities or partially or wholly transfers his activities to a third party, the party responsible for the liquidation of the company of the manufacturer (when registered), importer (when registered), downstream user or distributor or responsible for the marketing of the substance of the mixture concerned, is bound to the retention obligation mentioned in this framework instead of the manufacturer (when registered), importer (when registered), downstream user or distributor (see Article 36, section 2 Regulation (EC) no. 1907/2006).

(3) Various registrants wishing to register the same substance may unite in a so-called SIEF (“Substance Information Exchange Forum”). These are independent information exchange fora for substances which should lead to a joint submission for each substance led by the Lead Registrant. For more information see the Guideline for joint use of data of the European Chemicals Agency of januari 2017 (https://echa.europa.eu/documents/10162/23036412/guidance_on_data_sharing_en.pdf).

(4) Adequate documentation supporting the classification of mutagenic, carcinogenic, or reprotoxic mixture shall be retained and made available for review upon request (articles 3.5.3.2, 3.6.3.2, 3.7.3.2 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures).

(5) Not later than forty-eight hours before a mixture is placed on the market which is classified as dangerous based on regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, because of its effects on health or its physical effects, the importer or the downstream user responsible for placing it on the market forwards certain data to the National Centre for prevention and treatment of intoxications. A copy of the proof that the data have been forwarded to the National Centre for prevention and treatment of intoxications and a copy of the forwarded information should be retained (article 3 Royal Decree of April 21th, 2016 on notification of mixtures that can be classified as dangerous because of their effects on health or their physical effects to the National Centre for prevention and treatment of intoxications and amending Royal Decree of November 13th, 2011 on retributions and contributions to the Budget fund for raw materials and products). The Royal Decree does not provide a duration, but provides that the copies should be retained together with the information in article 49 of Regulation 1272/2008, regarding which the abovementioned retention period of 10 years applies.

(6) The supplier shall assemble and keep available all the information used by that supplier for the purposes of classification and labelling of the substance or the mixture for a period of at least 10 years after the substance or the mixture was last supplied by that supplier (article 49 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures).

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