Selling in the European Union?

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)).

Art. 6(1)

Must meet the conditions of Art. 6(1): act with due care in relation to applicable requirements when making a cosmetic product available

• 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)).

Art. 6(3)

Must meet the conditions of Art. 6(3): do not make a non-conforming product available until it is brought into conformity; ensure corrective measures, withdrawal or recall for products already made available

• 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)).

Art. 6(4)

Must meet the conditions of Art. 6(4): storage or transport conditions under the distributor's responsibility do not jeopardise compliance

• 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 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.

Distributors verify labelling, language and durability before making available

Test required

Distributor verification before making a product available: labelling information (Art. 19(1)(a), (e), (g), 19(3)-(4)), language requirements and date of minimum durability

• 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)).

Mandatory label element: nominal content

Label required

Nominal content at the time of packaging by weight or volume

• Net content at least 5 mL

Depends on: net content ml

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 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.

A no-animal-test claim is allowed only where no animal tests were carried out or commissioned

Must meet the conditions of Art. 20(3): a no-animal-testing claim only if neither the manufacturer nor its suppliers carried out or commissioned animal tests on the finished product, prototype or ingredients, or used ingredients tested on animals by others for developing new cosmetic products

• Claim: not tested on animals

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)).

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)).

PIF accessible to authority at address on label, in understandable language

Disclosure to authority

Make the product information file readily accessible at the address on the label, in a language easily understood by the authority

• 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)).

Public access to composition and undesirable effect data

Disclosure to consumer

Qualitative and quantitative composition (quantitative information limited to hazardous substances under CLP Art. 3), for perfume compositions the name, code number and supplier, and existing data on undesirable and serious undesirable effects, made easily accessible to the public

• 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)).

Responsible person keeps a product information file

Declaration required

Product information file, kept for ten years after the last batch was placed on the market, containing the product description, the safety report (Art. 10(1)), the manufacturing method and GMP statement, proof of the claimed effect where justified, and animal-testing data (Art. 11(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)).

A responsible person within the Community

Registration required

Designation of a responsible person established in the Union for each cosmetic product (Art. 4)

Every product in the category

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)).

Safety assessment and cosmetic product safety report before placing on the market

Test required

Safety assessment of the cosmetic product before placing it on the market and a cosmetic product safety report in accordance with Annex I

• 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)).

Must meet the conditions of Annex III entry 66: (a) Body- leave-on products | (a) Maximum residual acrylamide content 0,1 mg/kg

• Leave-on product

Depends on: rinse off

In force since 11 Jul 2013

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

No row-level date in the consolidated text for this entry; it applies from the Regulation's application date (Art. 40: 11 July 2013). Later amendments (the ▼M markers) are not dated row by row in the text.

From the consolidated text: Polyacrylamides · (a) Body- leave-on products

Identify supply chain on authority request, three years

Disclosure to authority

Identify distributors supplied (responsible person) or supplier and customers (distributor) for three years after batch made available

Every product in the category

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)).