Commission Regulation (EC) No 1852/2001 of 20 September 2001 laying down detailed rules for making certain information available to the public and for the protection of information submitted pursuant to European Parliament and Council Regulation (EC) No 258/97
Date: 2001-09-20
Institutions: European Commission
Subjects: access to information, application of EU law, consumer information, genetically modified organism, health policy, human nutrition

21.9.2001

EN

Official Journal of the European Communities

L 253/17

COMMISSION REGULATION (EC) No 1852/2001

of 20 September 2001

laying down detailed rules for making certain information available to the public and for the
protection of information submitted pursuant to European Parliament and Council Regulation (EC)
No 258/97

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European
Community,

Having regard to Regulation (EC) No 258/97 of the European
Parliament and of the Council of 27 January 1997 concerning
novel foods and novel food ingredients (1), and in particular
Article 4(5) and Article 10 thereof,

Whereas:

(1)

(2)

(3)

(4)

(5)

Experience has shown the need for detailed rules for the
protection of the information provided by applicants to
ensure the smooth functioning of the assessment of
applications under Regulation (EC) No 258/97.

These rules should ensure the confidentiality of informa-
tion relating to the manufacturing process where the
disclosure of such information might harm the competi-
tive position of
in a disproportionate
manner.

the applicant

In order to improve transparency in the operation of the
procedures established by Article 4 of Regulation (EC)
No 258/97, certain information about products being
assessed under that Article, and about the outcome of
the assessment should be made available to the public.
That
information should be made available by the
Commission on the Internet.

Such rules should be consistent with the new legislative
framework laid down in Directive 2001/18/EC of the
European Parliament and of the Council of 12 March
2001 on the deliberate release into the environment of
genetically modified organisms and repealing Council
Directive 90/220/EEC (2).

The measures provided for in this Regulation are in
accordance with the opinion of the Standing Committee
for Foodstuffs,

HAS ADOPTED THIS REGULATION:

Article 1

1.
The Commission, the national authorities of the Member
States and the food assessment bodies referred to in Article
4(3) of Regulation (EC) No 258/97 shall not divulge informa-
tion identified as confidential pursuant to paragraph 3, except
for information that must be made public if circumstances so
require in order to protect human health.

The applicant may indicate the information submitted by
2.
him pursuant to Regulation (EC) No 258/97 relating to the
manufacturing process that should be kept confidential because

(1) OJ L 43, 14.2.1997, p. 1.
(2) OJ L 106, 17.4.2001, p. 1.

its disclosure might harm his competitive position. Verifiable
justification must be given in such cases.

The competent authority of

3.
the Member, which has
received the application, shall determine, after consultation
with the applicant, which information relating to the manufac-
turing process shall be kept confidential and shall inform the
applicant,
food assessment body and the
Commission of its decision.

the competent

The Commission shall ensure that the Member States are
4.
informed of any decision communicated to it pursuant to
paragraph 3.

Article 2

1. When the initial assessment of the request is carried out
pursuant to Article 4(1) of Regulation (EC) No 258/97, the
Commission shall make the following information available to
the public:

(a) name and address of the applicant;

(b) description allowing the identification of the food or food

ingredient;

(c) intended use of the food or food ingredient;

(d) summary of the dossier, except for those parts for which
the confidential character has been determined in accord-
ance with Article 1(3);

(e) date of receipt of a complete request.

2.
The Commission shall make the initial assessment report
available to the public, except for any information identified as
in the following way:
confidential pursuant to Article 1(3),

(a) when there are no objections pursuant to Article 6(4) of
Regulation (EC) No 258/97. the initial assessment report
shall he made available to the public after the expiry of the
period of 60 days referred to in that Article and after the
time necessary for the information of the applicant;

(b) when, pursuant to Article 7 of Regulation (EC) No 258/97,
an authorisation decision is required, the initial assessment
report shall wherever possible be made available to the
public at
the Scientific
if no such opinion is
Committee for Food is given or,
required, at the time that the decision is published in the
Official Journal of the European Communities.

the same time the opinion of

Article 3

This Regulation shall enter
into force on the 20th day
following that of its publication in the Official Journal of the
European Communities.

L 253/18

EN

Official Journal of the European Communities

21.9.2001

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 20 September 2001.

For the Commission

David BYRNE

Member of the Commission