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CHAPTER-2: Substance evaluation
ARTICLE 46: Requests for further information and check of information submitted
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ARTICLE 46: Requests for further information and check of information submitted
1. If the competent authority considers that further information is required, including, if appropriate, information not required in Annexes VII to X, it shall prepare a draft decision, stating reasons, requiring the registrant(s) to submit the further information and setting a deadline for its submission. A draft decision shall be prepared within 12 months of the publication of the Community rolling action plan on the Agency's website for substances to be evaluated that year. The decision shall be taken in accordance with the procedure laid down in Articles 50 and 52.
2. The registrant shall submit the information required to the Agency by the deadline set.
3. The competent authority shall examine any information submitted, and shall draft any appropriate decisions in accordance with this Article, if necessary, within 12 months of the information being submitted.
4. The competent authority shall finish its evaluation activities within 12 months of the start of the evaluation of the substance or within 12 months of the information being submitted under paragraph 2, and notify the Agency accordingly. If this deadline is exceeded, the evaluation shall be deemed to be finished.
Referred by:
ARTICLE 22: Further duties of registrants
ARTICLE 45: Competent authority
ARTICLE 47: Coherence with other activities
ARTICLE 50: Registrants' and downstream users' rights
ARTICLE 52: Adoption of decisions under substance evaluation
ARTICLE 136: Transitional measures regarding existing substances