The REACH etc. (Amendment etc.) (EU Exit) Regulations 2019

PART 6 Amendment of Title 6: Evaluation

Chapter 1 of Title 6

31.—(1) Article 41 is amended as follows.

(2) In paragraph 2, for “Member States competent authorities” substitute “the appropriate authorities that request it”.

(3) In paragraph 5(c), omit “Community”.

(4) Omit paragraph 6.

(5) For paragraph 7 substitute—

“7.   The Secretary of State may, by regulations, make provision to modify the effect of paragraph 5 by—

(a) modifying the percentage of dossiers to be selected;

(b) modifying the criteria which determine the dossiers to which priority is to be given.

Regulations under this paragraph may amend paragraph 5.

The Secretary of State must consult the Agency before making regulations under this paragraph.

Regulations under this paragraph are to be made by statutory instrument; and a statutory instrument containing regulations under this paragraph is subject to annulment in pursuance of a resolution of either House of Parliament.

The function of making regulations under this paragraph is subject to the consent requirement in Article 4A.”.

32.  In Article 42(2)—

(a) in the first sentence, for “Commission and the competent authorities of the Member States” substitute “appropriate authorities that request the notification”;

(b) omit the second sentence.

33.—(1) Article 43 is amended as follows.

(2) In paragraph 2—

(a) omit points (a) and (b);

(b) in point (c)—

(i) for “2022” substitute “2023”;

(ii) after “received” insert “by ECHA”.

(3) In paragraph 3, for “Member States” substitute “appropriate authorities that request it”.

Chapter 2 of Title 6

34.—(1) Article 44 is amended as follows.

(2) In the first sentence of paragraph 1—

(a) for “In order to ensure a harmonised approach, the” substitute “The”;

(b) for “Member States” substitute “appropriate authorities”.

(3) In paragraph 2—

(a) in the first subparagraph—

(i) in the first sentence omit “Community”;

(ii) for the last two sentences substitute—

“The Agency must submit its draft rolling action plan to the appropriate authorities by 31 May 2020 and give the appropriate authorities the opportunity to comment on it. The Agency must submit a draft annual update to its rolling action plan by 31 May each year after 2020 and give the appropriate authorities the opportunity to comment on it. The Agency must adopt a final rolling annual action plan for each year (after taking account of any comments made on the draft by the appropriate authorities) and must publish it on its website.”;

(b) omit the last subparagraph.

35.—(1) Article 45 is amended as follows.

(2) For the heading substitute “Evaluation of substances on the rolling action plan”.

(3) In paragraph 1—

(a) in the first sentence omit—

(i) “coordinating the substance evaluation process and”;

(ii) “Community”;

(b) omit the last two sentences.

(4) Omit paragraphs 2 to 5.

36.—(1) Article 46 is amended as follows.

(2) In paragraph 1—

(a) in the first sentence for “competent authority” substitute “Agency”;

(b) in the second sentence, omit “Community”.

(3) In paragraph 3, for “competent authority” substitute “Agency”.

(4) In paragraph 4, in the first sentence—

(a) for “competent authority” substitute “Agency”;

(b) omit “, and notify the Agency accordingly”.

37.  Omit Article 47(2).

38.  For Article 48 substitute—

“Article 48 Follow-up to substance evaluation

Once the substance evaluation has been completed, the Agency must consider how to use the information obtained from this evaluation for the purposes of Article 59(3) and Article 69(4). The Agency must inform the appropriate authorities and the registrant of its conclusions as to whether or how to use the information obtained.”.

Chapter 3 of Title 6

39.  In Article 49—

(a) in the first subparagraph for “competent authority of the Member State in whose territory the site is located” substitute “Agency”;

(b) for the second subparagraph substitute—

“Where the appropriate authority in relation to the part of the United Kingdom where the site is located considers that a risk to human health or the environment, equivalent to the level of concern arising from the use of substances meeting the criteria in Article 57, arises from the use of an on-site isolated intermediate and that risk is not properly controlled, that appropriate authority may request the Agency to take the steps set out in points (a) and (b) of the first paragraph.

The Agency must inform the appropriate authorities that request them of the results of an assessment under this Article.”.

Chapter 4 of Title 6

40.—(1) Article 50 is amended as follows.

(2) In paragraph 1, omit the last two sentences.

(3) In paragraphs 2 and 3, in the last sentence, for the words from “competent authority” to the end substitute “appropriate authorities that request it, when a registrant has informed the Agency in accordance with this paragraph”.

(4) In paragraph 4(a), for “competent authority” substitute “Agency”.

41.  For Article 51 substitute—

“Article 51 Adoption of decisions under dossier evaluation

1.   This Article applies where the Agency has notified its draft decision in accordance with Article 40 or 41.

2.   If the Agency receives no comments from the registrant or downstream user, the Agency must make its decision in the version notified under paragraph 1.

3.   If the Agency receives any comments from the registrant or downstream user, the Agency must—

(a) take the comments into account, and

(b) make its decision (whether that is to make the decision in the version notified or vary the decision notified).

4.   The Agency must notify the registrant or downstream user and the appropriate authorities of the decision made under paragraph 2 or 3.

5.   An appeal may be brought, in accordance with Articles 91, 92 and 93 against a decision made under paragraph 2 or 3.”.

42.  For Article 52 substitute—

“Article 52 Adoption of decisions under substance evaluation

1.   This Article applies where the Agency has circulated its draft decision in accordance with Article 46.

2.   If the Agency receives no comments from the registrant or the downstream user, the Agency must make its decision in the version circulated under paragraph 1.

3.   If the Agency receives any comments from the registrant or the downstream user, the Agency must—

(a) take the comments into account, and

(b) make its decision (whether that is to make the decision in the version circulated or vary the decision circulated).

4.   The Agency must notify the registrant or the downstream user, and the appropriate authorities, of the decision made under paragraph 2 or 3.

5.   An appeal may be brought, in accordance with Articles 91, 92 and 93 against a decision made under paragraph 2 or 3.”.