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COUNCIL DIRECTIVE 93/99/EEC of 29 October 1993
on the subject of additional measures concerning the official control of
COUNCIL OF THE EUROPEAN COMMUNITIES,
reagard to the Treaty establishing the European Economic Community, and in
particular Article 100a thereof,
regard to the proposal from the Commission (1),
cooperation with the European Parliament (2),
regard to the opinion of the Economic and Social Committee(3),
it is necessary to adopt measures in the context of the internal market;
whereas the internal market comprises an area without internal frontiers in
which the free movement of goods, persons, services and capital is ensured;
trade in foodstuffs occupies a very important place in the internal market;
it is therefore essential that the application of Council directive 89/397/EEC
of 14 June 1989 on the official control of foodstuffs (4) is uniform throughout
the Member States; whereas this Directive lays down general rules on the
official control of foodstuffs;
there is a need for additional rules designed to improve the control procedures
in force in the Community;
Member States should take the necessary action to ensure that the staff of the
competent authorities have sufficient technical and administrative competence;
in order to guarentee the quality of the test data, a system of quality
standards should be introduced for laboratories entrusted by the Member States
with the official control of foodstuffs; whereas such a system should comply
with generally accepted and standardized norms; whereas, in addition, it is
essential that these laboratories use validated methods of analysis, whenever
the development of trade in foodstuffs between the various Member States
necessitates closer cooperation between the authorities involved in the control
general rules are required for the Commission officials specialized in the
control of foodstuffs who cooperate with specific officials of the Member
States in order to ensure the uniform application of legislation on foodstuffs;
provisions should be laid down under which the national authorities and the
Commission must provide mutual administrative assistance with a view to
ensuring proper application of the legislation on foodstuffs, in particular
through preventive action and the detection of infringements or behaviour
suspected of infringing the rules;
in view of the nature of the information exchanged pursuant to this Directive,
it should be covered by the requirements of commercial or professional secrecy;
a procedure should be provided for to establish close cooperation between the
Member States and the Commission,
ADOPTED THIS DIRECTIVE:
Directive supplements Directive 89/397/EEC.
the purposes of this Directive, the provisions of Article 1 (2), (3) and (4) of
Directive 89/397/EEC apply.
States shall ensure that the competent authorities have, or have access to, a
sufficient number of suitably qualified and experienced staff, in particular in
areas such as chemistry, food chemistry, veterinary medicine, medicine, food
microbiology, food hygiene, food technology and law so that the controls
referred to in Article 5 of Directive 89/397/EEC can be carried out adequately.
Member States shall take all measures necessary to ensure that the laboratories
referred to in Article 7 of Directive 89/397/EEC comply with the general
criteria for the operation of testing laboratories laid down in European
Standard EN 45001 supplemented by standard operating procedures and the random
audit of their compliance by quality assurance personnel, in accordance with
the OECD principles No 2 and 7 of good laboratory practice as set out in
Section II of Annex 2 to the Decision of the Council of the OECD of 12 May 1981
concerning the mutual acceptance of data in the assessment of chemicals.
assessing the laboratories referred to in Article 7 of Directive 89/397/EEC,
Member States shall:
apply the criteria laid down in European Standard EN 45002; and
require the use of proficiency testing schemes as far as appropriate.
meeting the assessment criteria shall be presumed to fulfil the criteria
referred to in paragraph 1.
which do not meet the assessment criteria shall not be considered as
laboratories referred to in Article 7 of the said Directive.
Member States shall designate bodies responsible for the assessment of
laboratories as referred to in Article 7 of Directive 89/397/EEC. These bodies
shall comply with the general criteria for laboratory accreditation bodies laid
down in European Standard EN 45003.
accreditation and assessment of testing laboratories referred to in this
Article may relate to individual tests or groups of tests. Any appropriate
deviation in the way in which the standards referred to in paragraphs 1, 2 and
3 are applied shall be adopted in accordance with the procedure laid down in
States shall ensure that the validation of methods of analysis used within the
context of official control of foodstuffs by the laboratories referred to in
Article 7 of Directive 89/397/EEC comply whenever possible with the provisions
of paragraphs 1 and 2 of the Annex to Council Directive 85/591/EEC of 23
December 1985 concerning the introduction of Community methods of sampling and
analysis for the monitoring of foodstuffs intended for human consumption (5).
1. The Commission shall appoint and designate
specific officials to cooperate with the competent authorities of the Member
States to monitor and evaluate the equivalence and effectiveness of official
food control systems operated by the competent authorities of the Member
States. The Commission shall send regular reports to the Member States
concerned on the work of its specific officials.
Commission shall ensure that such officials are suitably qualified and possess
the appropriate knowledge and experience to carry out this task; detailed rules
of application may be adopted in accordance with the procedure laid down in
competent authorities of the Member States shall cooperate with the
Commission's designated officials and give all the necessary assistance to
enable them to accomplish their tasks.
pursuante of the duties set out in paragraph 1, Member States shall permit the
Commission's designated officials to accompany the officials of their competent
authorities carrying out the operations provided for in Article 5 of Directive
89/397/EEC. In any event, the officials of the competent authorities of the
Member States shall remain responsible for the carrying out of the control
Commission shall give Member States at least five working days' notice before
the start of these operations. After the execution of each operation referred
to in this paragraph the Commission shall forward a report on the work of its
specific officials to the Member States concerned.
purpose of the operations referred to in this paragraph, the Commission's
designated officials shall produce written authorization specifying their
identity and status.
Commission's designated officials shall comply with the rules and practices
which officials of the competent authorities of the Member States must follow.
Commission shall present an annual report to the Member States and to the
European Parliament on the implementation of this Article.
competent authorities of the Member States shall afford each other
administrative assistance in all supervisory procedures in connection with
legal provisions and quality standards applicable to foodstuffs and in all
proceedings for infringements of the law applicable to foodstuffs.
facilitate this administrative assistance each Member State shall designate a
single liaison body. It shall be for the body designated by the Member State to
liaise as appropriate with the liaison bodies of other Member States. The role
of the bodies shall be to assist and coordinate communication and, in
particular, the transmission and reception of requests for assistance.
Member States shall inform the Commission of all the relevant details of their
designated liaison body. The list of designated liaison bodies and the relevant
details shall be published in the'C' series of the Official Journal of the
receiving a reasoned request, the body concerned shall be responsible for
ensuring that the requesting body is provided with all necessary information,
except that which cannot be released because it is the subject of legal
proceedings, enabling that body to guarantee compliance with legal provisions
and quality standards applicable to foodstuffs within its jurisdiction.
information and documents provided pursuant to paragraph 4 shall be forwarded
without undue delay either through the liaison body or directly, as
appropriate. When original documents cannot be sent, copies of the documents
may be transmitted.
during the exchange of information, it becomes clear that there may have been a
case of non-compliance of Community laws or rules or national law of either the
receiving Member State or the sending Member State, the competent authority in
the Member State in whose territory the alleged non-compliance has taken place
shall in due time report back to the competent authority in the other Member
- on any
action that may have been undertaken to deal with the alleged non-compliance,
- on any
action which has taken, including any action to try to prevent a reoccurrence
of the alleged non-compliance.
report may also be copied to the Commission on the initiative of either the
transmitting or the receiving Member State.
Article shall apply without prejudice to Council Decision 89/45/EEC of 21
December 1988 on dangers arising from the use of consumer products (6) and
Council Directive 92/59/EEC on general product safety (7).
Information forwarded pursuant to Article 6 of this Directive, in whatever
form, is covered by professional secrecy. In criminal proceedings, the
information can be used only with the prior consent of the sending Member State
in accordance with, for those Member States who are parties to them, the
international conventions and agreements in force on mutual assistance in
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