Selling in the European Union?

Art. 13(2)

Notification to Commission (CPNP)

Original labelling and, where reasonably legible, a photograph of the corresponding packaging

• Your role: Manufacturer or Importer

Depends on: economic operator role

In force since 11 Jul 2013

Applies to products placed on the market on or after 11 Jul 2013

Art. 40(2): the Regulation applies from 11 July 2013; this article is not among the exceptions listed there (Art. 15(1)-(2), 14/31/32 as needed for Art. 15, and the second subparagraph of Art. 16(3)).

Product notification before placing on the market (EU CPNP / GB SCPN)

Notification to European Commission (CPNP)

Category and name of the product; name and address of the responsible person where the product information file is kept; country of origin if imported; Member State of placing on the market; contact details of a natural person; presence of nanomaterials and their identification and reasonably foreseeable exposure conditions; name and CAS or EC number of CMR 1A/1B substances; frame formulation; original labelling and, where legible, a photograph of the packaging (Art. 13(2))

• Your role: Manufacturer or Importer

Depends on: economic operator role

In force since 11 Jul 2013

Applies to products placed on the market on or after 11 Jul 2013

Art. 40(2): the Regulation applies from 11 July 2013; this article is not among the exceptions listed there (Art. 15(1)-(2), 14/31/32 as needed for Art. 15, and the second subparagraph of Art. 16(3)).

Notification of authorities where the product presents a risk to human health

Notification to Competent national authorities of the Member States in which the product was made available and of the Member State where the product information file is readily accessible

Details of the non-compliance and of the corrective measures taken

• Your role: Manufacturer or Importer

Depends on: economic operator role

In force since 11 Jul 2013

Applies to products placed on the market on or after 11 Jul 2013

Art. 40(2): the Regulation applies from 11 July 2013; this article is not among the exceptions listed there (Art. 15(1)-(2), 14/31/32 as needed for Art. 15, and the second subparagraph of Art. 16(3)).

Distributor informs RP and authorities of risk

Notification to Responsible person and competent authorities

Details of non-compliance and corrective measures taken

• Your role: Distributor

Depends on: economic operator role

In force since 11 Jul 2013

Applies to products distributed on or after 11 Jul 2013

Art. 40(2): the Regulation applies from 11 July 2013; this article is not among the exceptions listed there (Art. 15(1)-(2), 14/31/32 as needed for Art. 15, and the second subparagraph of Art. 16(3)).

Distributor that translates labelling notifies the Commission

Notification to European Commission (CPNP)

Category, names in both Member States, Member State of availability, distributor name and address, responsible person

• Your role: Distributor

Depends on: economic operator role

In force since 11 Jul 2013

Applies to products distributed on or after 11 Jul 2013

Art. 13(3): 'As from 11 July 2013' (stated in the provision); Art. 40(2) is consistent.

Notification of cosmetic products containing nanomaterials six months before placing on the market

Notification to European Commission

Nanomaterial identification (IUPAC name and descriptors), specification (particle size, physical and chemical properties), estimated annual quantity, toxicological profile, safety data for the product category, reasonably foreseeable exposure conditions; six months before placing on the market

• Contains a nanomaterial
• Your role: Manufacturer or Importer

Depends on: contains nanomaterial, economic operator role

In force since 11 Jul 2013

Applies to products placed on the market on or after 11 Jul 2013

Art. 40(2): the first subparagraph of Art. 16(3) applies from 11 July 2013 with the Regulation; only the second subparagraph (products already on the market, notification between 11 January 2013 and 11 July 2013) applies from 11 January 2013 and is a transitional duty not listed as a separate rule.

Update of notified information when it changes

Notification to European Commission (CPNP)

Update, without delay, of any changed information notified under Art. 13(1), (3) or (4)

• Your role: Manufacturer or Importer or Distributor

Depends on: economic operator role

In force since 11 Jul 2013

Applies to products placed on the market on or after 11 Jul 2013

Art. 40(2): the Regulation applies from 11 July 2013; this article is not among the exceptions listed there (Art. 15(1)-(2), 14/31/32 as needed for Art. 15, and the second subparagraph of Art. 16(3)).

Notify serious undesirable effects

Notification to Competent authority of the Member State where the serious undesirable effect occurred

All serious undesirable effects known or reasonably expected to be known, the name of the product enabling identification, and any corrective measures taken

• Your role: Manufacturer or Importer or Distributor

Depends on: economic operator role

In force since 11 Jul 2013

Applies to products placed on the market on or after 11 Jul 2013

Art. 40(2): the Regulation applies from 11 July 2013; this article is not among the exceptions listed there (Art. 15(1)-(2), 14/31/32 as needed for Art. 15, and the second subparagraph of Art. 16(3)).