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TITLE-VI: EVALUATION
CHAPTER-2: Substance evaluation
ARTICLE 45: Competent authority
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ARTICLE 45: Competent authority
1. The Agency shall be responsible for coordinating the substance evaluation process and ensuring that substances on the Community rolling action plan are evaluated. In doing so, the Agency shall rely on the competent authorities of Member States. In carrying out an evaluation of a substance, the competent authorities may appoint another body to act on their behalf.
2. A Member State may choose (a) substance(s) from the draft Community rolling action plan, with the aim of becoming a competent authority for the purposes of Articles 46, 47 and 48. In the event of a substance from the draft Community rolling action plan not being chosen by any Member State, the Agency shall ensure that the substance is evaluated.
3. In cases where two or more Member States have expressed an interest in evaluating the same substance and they cannot agree who should be the competent authority, the competent authority for the purposes of Articles 46, 47 and 48 shall be determined in accordance with the following procedure.
The Agency shall refer the matter to the Member State Committee, in order to agree which authority shall be the competent authority, taking into account the Member State in which the manufacturer(s) or importer(s) is located, the respective proportions of total Community gross domestic product, the number of substances already being evaluated by a Member State and the expertise available.
If, within 60 days of the referral, the Member State Committee reaches unanimous agreement, the Member States concerned shall adopt substances for evaluation accordingly.
If the Member State Committee fails to reach a unanimous agreement, the Agency shall submit the conflicting opinions to the Commission, which shall decide which authority shall be the competent authority, in accordance with the procedure referred to in Article 133(3), and the Member States concerned shall adopt substances for evaluation accordingly.
4. The competent authority identified in accordance with paragraphs 2 and 3 shall evaluate the allocated substances in accordance with this Chapter.
5. A Member State may notify the Agency at any time of a substance not on the Community rolling action plan, whenever it is in possession of information which suggests that the substance is a priority for evaluation. The Agency shall decide whether to add this substance to the Community rolling action plan on the basis of an opinion from the Member State Committee. If the substance is added to the Community rolling action plan, the proposing Member State, or another Member State who agrees, shall evaluate that substance.
Referred by:
ARTICLE 42: Check of information submitted and follow-up to dossier evaluation
ARTICLE 44: Criteria for substance evaluation
ARTICLE 135: Transitional measures regarding notified substances