EU Notification

Notifications

C&L Notification

When the CLP entered into force, the requirement for the notification of classification and labelling moved from REACH to the CLP.

Poison Centres

The legal basis for the notification of formulations to a particular poison centre, national authority, etc., is set out in Article 45 of the CLP (EU Regulation (EC) 1272/2008) and the national legislation of those EU Member States where such products are placed on the market.  Article 45 requires manufacturers or importers to submit information on hazardous mixtures to the designated body of the Member State where the mixture is placed on the market. 

Substances in Articles

Substances on the Candidate List of Substances of Very High Concern for Authorisation require Notification to ECHA if they are present in articles above 0.1% and in total volumes above 1 tonne per year.

Prior Informed Consent

Regulation (EC) No 689/2008 (Prior Informed Consent Regulation, PIC) implements the Rotterdam Convention on the prior informed consent procedure for certain hazardous chemicals and pesticides in international trade in the European Union. The regulation requires that exports of certain chemicals to non-EU countries must be notified to the designated member state authority.

C&L Notification

When the CLP entered into force, the requirement for the notification of classification and labelling moved from REACH to the CLP. 

According to Article 40 of the CLP, a substance must be notified to the C&L inventory by the EU based manufacturer/importer if:

  • the substance is subject to registration under REACH; or
  • the substance is classified as hazardous (as result of a harmonised classification or a self-classification), irrespective of the quantity; or
  • the substance is part of a mixture that is classified as hazardous and is present above the relevant concentration limit, which results in the classification of the mixture as hazardous according to the CLP Regulation; or
  • the substance is contained in an article and subject to registration under Article 7 of the REACH Regulation.

The notification must be submitted to ECHA within one month of placing it on the market. This notification may also be completed by a “group” of manufacturers or importers. 

Submission of a Registration dossier, which includes the Classification and Labelling information, constitutes having fulfilled the C&L Notification requirement.

The information to be notified to ECHA must include the following points:

  • The identity of the notifier(s) responsible for placing the substance or substances on the market as specified in Annex VI to REACH
  • The identity of the substance or substances as specified in section 2.1-2.3.4 in Annex VI to REACH
  • The classification of the substance or substances according to Article 13 of the CLP
  • An indication as to why the substance or substances has (have) not been classified in hazard classes and categories not mentioned in point 3 above. The following justifications are possible: lack of data; inconclusive data; or data which are conclusive although insufficient for classification
  • Specific concentration limits or M-factors where applicable along with an appropriate justification
  • The label elements specified in Article 17 (d, e, f) which include hazard pictograms, signal words and hazard statements. Supplemental hazard statements in accordance with Article 25(1) are also required.

According to Article 41, where the notification results in different entries in the C&L Inventory, notifiers and registrants will be required to “make every effort” to reach an agreed entry.

Poison Centres

The legal basis for the notification of formulations to a particular poison centre, national authority, etc., is set out in Article 45 of the CLP (EU Regulation (EC) 1272/2008) and the national legislation of those EU Member States where such products are placed on the market.  Article 45 requires manufacturers or importers to submit information on hazardous mixtures to the designated body of the Member State where the mixture is placed on the market.  

Hazardous mixtures may be notified electronically or by mail, with varying data requirements, depending on the Member State. A draft CLP amendment to add an Annex VIII has been developed to harmonize the submission under Article 45. This is expected to come into force in 2017. A new Poison Centre website and a related online submission tool and format has been established by ECHA to gradually replace the national requirements. 

The draft also includes provisions for Unique Formula Identifiers (UFI): unique number codes that will be established and linked to a particular hazardous mixture. The UFI will have to be printed on the label or the packaging of the mixture to allow a quick identification of the specific chemical formulation of a product and a fast appropriate response in case of an emergency call. The UFI generator is already available and UFIs can be generated one at a time or in bulk.

The online tool and the new format will gradually replace the national requirements. Based on the draft tool, each submission will be tied to the UFI and also include:

  • Company information, including but not limited to: Address, telephone, and e-mail address;
  • VAT number of the submitting legal entity;
  • Additional contact information, including an all-hours telephone number in the case of a limited submission (industrial use only).
  • Product Identification (can have multiple per submission), including but not limited to: Trade name;
  • User type (consumer, industrial, professional) and product category (based on the Product Categorisation System, once adopted);
  • Safety Data Sheet (SDS) as attachment (optional);
  • Product packaging type and size (e.g. 10 mL soluble packaging; multiple combinations can be added per product).
  • Mixture information (unique per submission): UFI;
  • Physical state, color, pH and relevancy;
  • Toxicological information that would be included in Section 11 of an SDS;
  • CLP classification and labelling information.
  • Composition: Substances, mixtures in mixture and generic components can be added:

For substances, classifications must be specified;

  • For mixtures within the mixture, UFI, mixture name, and company information must be specified;
  • Generic components means perfumes/fragrances or colouring agents.

Substances in Articles

Substances on the Candidate List of Substances of Very High Concern for Authorisation require Notification to ECHA if they are present in articles above 0.1% and in total volumes above 1 tonne per year. 

According to REACH Article 7, notification of Substances of Very High Concern (SVHC) in articles is required by the manufacturer/importer if:

  • The substance is present in articles above a concentration of 0.1% (w/w)
  • The total amount of the substance present in all articles produced and/or imported, which contain more than 0.1% (w/w) of the substance, exceeds 1 tonne per actor per year

The notification is due 6 months after a substance has been included on the Candidate List of Substances of Very High Concern for Authorisation. A notification is not required if the substance has already been registered for that use.

The Notification to ECHA shall contain the following information:

  • Manufacturer/importer identity and contact details
  • Registration number, if available
  • Tonnage range of the substance
  • A brief description of the use of the substance in the article
  • Uses of the article

The Notification can be done online in REACH IT or using IUCLID.

If an article contains an SVHC from the candidate list in a concentration above 0.1%, relevant safety information about this substance must be provided to the recipient of these articles (REACH Article 33). Upon request, this information must also be provided to consumers within 45 days.

Prior Informed Consent

Export Notification of Substances Subject to PIC

Regulation (EC) No 689/2008 (Prior Informed Consent Regulation, PIC) implements the Rotterdam Convention on the prior informed consent procedure for certain hazardous chemicals and pesticides in international trade in the European Union. The regulation requires that exports of certain chemicals to non-EU countries must be notified to the designated member state authority. The list of chemicals affected is available in Annex I of EU Regulation (EC) No 689/2008.

Exports of all chemicals, mixtures, or articles that contain one or more chemicals subject to PIC must be notified in advance, at least 35 days before the first export. The Notification is created and submitted via the IT system ePIC. ePIC enables the information exchange between industry users, authorities and custom. The required information is listed in Annex II of the PIC Regulation. Once notified, a unique identifier is assigned (reference identification number).