Hazardous Mixtures And Health Emergency, Are You Ready For The January 1, 2021 Deadline?

• Published date: 29 December 2020
• Subject Matter: Corporate/Commercial Law, Food, Drugs, Healthcare, Life Sciences, Corporate and Company Law
• Law Firm: Soulier Avocats
• Author: Ms Laure Marolleau

Companies placing hazardous mixtures on the market have to submit information about these mixtures to specific bodies appointed by European Union Member States. Poison centers use this information to give medical advice in case of an emergency.

The notification requirement, based on Annex VIII to the Classification, Labelling and Packaging (CLP) Regulation, applies from 1 January 2021.

The addition of this new Annex VIII relating to harmonized information relating to emergency health response, implemented in 2017, pursues the objective of harmonizing at the European level the information to be provided and the format for notifying hazardous mixtures placed on the market and, as such, making the management of health emergencies related to these products more consistent.

Who needs to make a notification?

New Annex VIII applies to all importers and downstream users placing on the market mixtures that are classified as hazardous based on their physical and health effects.

When does the notification obligation start to apply?

The date from which the notification obligation starts to apply varies depending on the contemplated end use of the mixture:

• mixtures for consumer use: January 1 2021;
• mixtures for professional use January 1, 2021;
• mixtures for industrial use: January 1, 2024.

If a mixture has more than one of the above uses - whether through direct use or through its presence in a product manufactured further down the supply chain - the earliest date applies.

Before the relevant applicability date, the mixture continues to be subject to existing national information requirements (in France, notifications are until now made through the online platform called Declaration-Synapse¹).

Mixtures already notified under national legislation shall remain valid until January 1, 2025. If there is a change to the mixture before this date, companies may need to make a notification based on the new information requirements according to Annex VIII.

What mixtures are subject to the notification requirement?

Annex VIII does not apply to:

• mixtures for scientific research and development and to mixtures for product and process oriented research and development (PPORD),

• mixtures classified only for the following hazards: gases under pressure and explosives.

In case of mixtures placed on the market for industrial use only, submitters may opt for a limited submission, as an alternative to general submission requirements. In that case, the information to be submitted...