Version in force , Modified +1,114 −54§
Amended by Regulation (EU) 2024/2865 32024R2865 on EUR-Lex (external, EUR-Lex)
Explanation, written by a model and checked against the cited text
Three new paragraphs are added: paragraph 1a allows Member States to appoint the Agency as the body receiving the emergency health response information described in paragraph 1, paragraph 1b requires importers and downstream users placing hazardous mixtures on the market to submit the Part B Annex VIII information to the appointed body or bodies, and paragraph 1c imposes a similar submission duty on distributors placing such mixtures on the market when they subsequently distribute, rebrand or relabel them in other Member States, with an exemption if the same information was already received from importers and downstream users.
Paragraph 3 is reworded so that the appointed bodies must have at their disposal information required from importers, downstream users and the distributors referred to in new paragraph 1c, rather than only from importers and downstream users responsible for marketing, and the reference now ties the tasks to paragraph 1.
Cited: Art. 45, v2 (external, EUR-Lex) · Art. 45, v1 (external, EUR-Lex)
v1 is the previous version, v2 this one.
Text from EUR-Lex, before and after
Previous version, in force 1 July 2026 02008R1272-20260701 → this version, in force 1 January 2027 02008R1272-20270101
Article 45
Appointment of bodies responsible for receiving information relating to emergency health response
1. Member States shall appoint a body or bodies responsible for receiving the relevant harmonised information relating to emergency health response and preventative measures, in accordance with Annex VIII.
1a. Member States may appoint the Agency as the body responsible for receiving information relating to emergency health response and preventative measures referred to in paragraph 1.
1b. Importers and downstream users placing on the market mixtures that are classified as hazardous on the basis of their health or physical effects, shall submit to the body or bodies appointed in accordance with paragraph 1 the information referred to in Part B of Annex VIII.
1c. Distributors placing on the market mixtures that are classified as hazardous on the basis of their health or physical effects shall submit to the body or bodies appointed in accordance with paragraph 1 the information referred to in Part B of Annex VIII where they subsequently distribute those mixtures in other Member States, or where they rebrand or relabel the mixtures. That obligation shall not apply if the distributors can demonstrate that the appointed body or bodies already received the same information from importers and downstream users.
2. The appointed bodies shall provide all requisite guarantees for maintaining the confidentiality of the information received. Such information may only be used:
(a) to meet medical demand by formulating preventative and curative measures, in particular in the event of an emergency;
and
(b) where requested by the Member State, the Commission or the Agency, to undertake a statistical analysis to identify where improved risk management measures may be needed.
The information shall not be used for other purposes.
3. The appointed bodies shall have at their disposal all the information required from the importers and importers, downstream users responsible for marketing and distributors referred to in paragraph 1c, to carry out the tasks for which they are responsible. responsible in accordance with paragraph 1.
4. The Commission is empowered to adopt delegated acts in accordance with Article 53a amending Annex VIII to further harmonise the information relating to emergency health response and preventative measures, following consultation with relevant stakeholders such as the European Association of Poison Centres and Clinical Toxicologists (EAPCCT).