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 importers,the importers and downstream users andresponsible distributorsfor referred to in paragraph 1c,marketing to carry out the tasks for which they are responsible in accordance with paragraph 1.responsible.
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).