Article 3 — Amendments to Regulation (EU) 2017/745

Annex I to Regulation (EU) 2017/745 is amended as follows: (1) in Section 10.4.1, point (b) is replaced by the following: (b) substances which are classified as endocrine disruptors for human health, of Category 1, in accordance with Part 3 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council and substances having endocrine-disrupting properties for which there is scientific evidence of probable serious effects to human health and which are identified in accordance with the procedure set out in Article 59 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council or substances having endocrine-disrupting properties relevant to human health identified in accordance with Regulation (EU) No 528/2012 of the European Parliament and the Council. (2) in Section 10.4.2, point (d) is replaced by the following: (d) where applicable and available, the latest relevant guidelines in accordance with Sections 10.4.3 and 10.4.4 ; (3) Section 10.4.3 is replaced by the following: 10.4.3. Guidelines on phthalates When deemed appropriate based on the latest scientific evidence, but at least every 5 years, the Commission shall request the European Chemicals Agency (ECHA) to prepare and update guidelines on the benefit-risk assessment of the presence of phthalates which belong to either of the groups of substances referred to in Section 10.4.1, points (a) and (b). The benefit-risk assessment shall consider the intended purpose and context of the use of the device, as well as any available alternative substances and alternative materials, designs or medical treatments. When appropriate or when requested by the Commission, the ECHA shall consult the Committee for Risk Assessment and the Committee for Socio-economic Analysis. ; (4) Section 10.4.4 is replaced by the following: 10.4.4. Guidelines on other CMR and endocrine-disrupting substances In addition to the guidelines referred to in Section 10.4.3, the Commission shall request the ECHA to prepare such guidelines for other substances referred to in Section 10.4.1, points (a) and (b), where appropriate. Such guidelines shall be prepared in accordance with the process described in Section 10.4.3..