CHAPTER IIU.K.COMMON PROCEDURE

Article 3U.K.Main stages of the common procedure

1.The common procedure for [F1determining the authorisation status of a substance] may be started either on the initiative of the [F2Authority] or following an application. Applications may be made F3... by an interested party, who may represent several interested parties, in accordance with the conditions provided for by [F4Regulation 234/2011]. Applications shall be sent to the [F5appropriate authority].

2.The [F6appropriate authority] shall seek the opinion of the [F7Authority], to be given in accordance with Article 5.

However, for [F8a determination of the authorisation status of a substance described in Article 2B(1)(b) or (c)], the [F6appropriate authority] shall not be required to seek the opinion of the Authority if [F9any changes as a result of the determination] in question are not liable to have an effect on human health.

[F103.The common procedure is to end with the appropriate authority [F11determining the authorisation status of the substance concerned], in accordance with Article 7.]

4.By way of derogation from paragraph 3, the [F12appropriate authority] may end the common procedure and decide not to proceed with [F13determining the authorisation status of a substance], at any stage of the procedure, if it judges that such [F14a determination] is not justified. Where applicable, it shall take account of the opinion of the Authority, F15..., any relevant provisions of [F16assimilated] law and any other legitimate factors relevant to the matter under consideration.

In such cases, where applicable, the [F17appropriate authority] shall inform the applicant F18... directly, indicating in its letter the reasons for not [F19determining the authorisation status of the substance concerned].

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Article 4U.K.Initiating the procedure

1.On receipt of an application to [F20determine the authorisation status of a substance], the [F21appropriate authority]:

(a)shall acknowledge receipt of the application in writing to the applicant within 14 working days of receiving it;

(b)where applicable, shall as soon as possible notify the Authority of the application and request its opinion in accordance with Article 3(2).

F22...

F232.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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Article 5U.K.Opinion of the Authority

1.The Authority shall give its opinion within nine months of receipt of a valid application.

2.The Authority shall forward its opinion to the [F24appropriate authority] and, where applicable, the applicant.

Textual Amendments

Article 6U.K.Additional information concerning risk assessment

1.In duly justified cases where the Authority requests additional information from applicants, the period referred to in Article 5(1) may be extended. After consulting the applicant, the Authority shall lay down a period within which this information can be provided F25....

2.If the additional information is not sent to the Authority within the additional period referred to in paragraph 1, the Authority shall finalise its opinion on the basis of the information already provided.

3.Where applicants submit additional information on their own initiative, they shall send it to the Authority F26.... In such cases, the Authority shall give its opinion within the original period without prejudice to Article 10.

F274.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Article 7U.K.[F28Determination of authorisation status and amendment of sectoral food laws]

[F291.Within nine months of receiving the opinion of the Authority, the appropriate authority must [F30determine the authorisation status of the substance concerned,] taking into account the opinion of the Authority, any relevant provisions of [F31assimilated] law and any other legitimate factors relevant to the matter under consideration.

In those cases where the Authority has not given an opinion, the nine month period starts from the date the appropriate authority receives a valid application.]

[F321A.Where the appropriate authority makes a determination as to the authorisation status of a substance:

(a)the appropriate authority must:

(i)specify the date on which the authorisation, modification, suspension or revocation is to have effect; and

(ii)communicate the determination to the Authority;

(b)the Authority must update the domestic list referred to in Article 2C accordingly.]

F332.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F343.Where the [F35determination] is not in accordance with the opinion of the Authority, the appropriate authority must explain the reasons for its [F35determination].]

4.The measures, designed to amend non-essential elements of each sectoral food law, relating to the [F36revocation of the authorisation of substances generally], [F37may be prescribed by the appropriate authority after seeking advice from the Authority].

5.On grounds of efficiency, the measures designed to amend non-essential elements of each sectoral food law, inter alia, by supplementing it, relating to the [F38authorisation of substances generally] and for [F39modifying] conditions, specifications or restrictions associated with the [F40authorisation of substances generally], [F41may be prescribed by the appropriate authority after seeking advice from the Authority].

F426.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Article 8U.K.Additional information concerning risk management

1.Where the [F43Authority] requests additional information from applicants on matters concerning risk management, it shall determine, together with the applicant, a period within which that information can be provided. In such cases, the period referred to in Article 7 may be extended accordingly. F44...

2.If the additional information is not sent within the additional period referred to in paragraph 1, the [F45Authority] shall act on the basis of the information already provided.

Textual Amendments