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The Authority may, where appropriate, request the appli-
cant to supplement the particulars accompanying the application
within a time limit specified by the Authority. Where the Author-
ity requests supplementary information, the time limit laid down
in paragraph 1 shall be suspended until that information has been
provided. Similarly, the time limit shall be suspended for the time
allowed the applicant to prepare oral or written explanations.
In order to prepare its opinion, the Authority shall:
(a) verify that the information and documents submitted by the
applicant are in accordance with Article 9(1)(a), in which case
the application shall be regarded as valid, and examine
whether the substance complies with the safety criteria laid
down in Article 3 and, where they apply, Article 4;
(b) inform the applicant, the Commission and the Member States
if an application is not valid.
In the event of an opinion in favour of authorising the
evaluated substance, the opinion shall include:
(a) the designation of the substance including its specifications;
(b) where appropriate, recommendations for any conditions or
restrictions of use for the evaluated substance and/or the
material or article in which it is used;
(c) an assessment as to whether the analytical method proposed
is appropriate for the intended control purposes.
The Authority shall forward its opinion to the Commission,
the Member States and the applicant.
The Authority shall make its opinion public, after deletion
of any information identified as confidential, in accordance with
Article 20.
Article 11
Community authorisation
The Community authorisation of a substance or substances
shall take place in the form of the adoption of a specific measure.
The Commission shall, where appropriate, prepare a draft of a
specific measure, as referred to in Article 5, to authorise the sub-
stance or substances evaluated by the Authority and specify or
change the conditions of its or their use.
The draft specific measure shall take into account the opin-
ion of the Authority, relevant provisions of Community law and
other legitimate factors relevant to the matter under consider-
ation. Where the draft specific measure is not in accordance with
the opinion of the Authority, the Commission shall provide with-
out delay an explanation for the reasons for the differences. If the
Commission does not intend to prepare a draft specific measure
after a favourable opinion by the Authority, it shall inform the
applicant without delay and provide the applicant with an
Community authorisation in the form of a specific measure,
as referred to in paragraph 1, shall be adopted in accordance with
the procedure referred to in Article 23(2).
After the authorisation of a substance in accordance with
this Regulation, any business operator using the authorised sub-
stance or materials or articles containing the authorised substance
shall comply with any condition or restriction attached to such
The applicant or any business operator using the authorised
substance or materials or articles containing the authorised sub-
stance shall immediately inform the Commission of any new sci-
entific or technical information, which might affect the safety
assessment of the authorised substance in relation to human
health. If necessary, the Authority shall then review the
The granting of an authorisation shall not affect the general
civil and criminal liability of any business operator in respect of
the authorised substance, the material or article containing the
authorised substance, and the food that is in contact with such
material or article.
Article 12
Modification, suspension and revocation of authorisation
The applicant or any business operator using the authorised
substance or materials or articles containing the authorised sub-
stance may, in accordance with the procedure laid down in
Article 9(1), apply for modification of the existing authorisation.
The application shall be accompanied by the following:
(a) a reference to the original application;
(b) a technical dossier containing the new information in accor-
dance with the guidelines referred to in Article 9(2);
(c) a new complete summary of the technical dossier in a stan-
dardised form.
L 338/10
Official Journal of the European Union