(n) specific procedural rules adapting, as necessary, the proce-
dure referred to in Articles 8 to 12, or making it appropriate
for the authorisation of certain types of materials and articles
and/or processes used in their manufacture, including,
where necessary, a procedure for an individual authorisation
of a substance, process, or material or article through a deci-
sion addressed to an applicant.
Existing specific directives on materials and articles shall be
amended in accordance with the procedure laid down in
National specific measures
In the absence of specific measures referred to in Article 5, this
Regulation shall not prevent Member States from maintaining or
adopting national provisions provided they comply with the rules
of the Treaty.
Role of the European Food Safety Authority
Provisions liable to affect public health shall be adopted after con-
sulting the European Food Safety Authority, hereinafter referred
to as `the Authority'.
General requirements for the authorisation of substances
When a list of substances as referred to in points (a) and (b)
of the second subparagraph of Article 5(1) is adopted, anyone
seeking an authorisation for a substance not yet included in that
list shall submit an application in accordance with Article 9(1).
No substance shall be authorised unless it has been
adequately and sufficiently demonstrated that, when used under
the conditions to be set in the specific measures, the final mate-
rial or article satisfies the requirements of Article 3 and, where
they apply, Article 4.
Application for authorisation of a new substance
To obtain the authorisation referred to in Article 8(1), the
following procedure shall apply:
(a) an application shall be submitted to the competent authority
of a Member State accompanied by the following:
(i) the name and address of the applicant;
(ii) a technical dossier containing the information specified
in the guidelines for the safety assessment of a substance
to be published by the Authority;
(iii) a summary of the technical dossier;
(b) the competent authority referred to in (a) shall:
(i) acknowledge receipt of the application in writing to the
applicant within 14 days of its receipt. The acknowl-
edgement shall state the date of receipt of the
(ii) inform the Authority without delay;
(iii) make the application and any supplementary informa-
tion supplied by the applicant available to the Authority;
(c) the Authority shall without delay inform the other Member
States and the Commission of the application and shall make
the application and any supplementary information supplied
by the applicant available to them.
The Authority shall publish detailed guidelines concerning
the preparation and the submission of the application (
Opinion of the Authority
The Authority shall give an opinion within six months of
the receipt of a valid application, as to whether, under the intended
conditions of use of the material or article in which it is used, the
substance complies with the safety criteria laid down in Article 3
and, where they apply, Article 4.
The Authority may extend the said period by a maximum period
of a further six months. In such a case it shall provide an expla-
nation for the delay to the applicant, the Commission and the
) Pending such publication, applicants may consult the `Guidelines of
the Scientific Committee on Food for the presentation of an applica-
tion for safety assessment of a substance to be used in food contact
materials prior to its authorisation'.
Official Journal of the European Union