1985L0591 — EN — 20.11.2003 — 001.001 — 1
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►B COUNCILDIRECTIVE
of20December 1985
concerning the introduction of Community methods of sampling and analysis for the monitoring
offoodstuffsintendedforhumanconsumption
(85/591/EEC)
(OJ L 372, 31.12.1985, p. 50)
Amended by:
Official Journal
No page date
►M1Regulation (EC) No 1882/2003 of the European Parliament and of the
Council of 29 September 2003L 284 1 31.10.2003
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COUNCILDIRECTIVE
of20December 1985
concerning the introduction of Community methods of sampling
and analysis for the monitoring of foodstuffs intended for human
consumption
(85/591/EEC)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Economic
Community, and in particular Article 100 thereof,
Having regard to the proposal from the Commission (1),
Having regard to the opinion of the European Parliament (2),
Having regard to the opinion of the Economic and Social
Committee (3),
Whereas the production, manufacture, marketing and use of foodstuffs
intended for human consumption are of considerable importance in theEuropean Economic Community;
Whereas the methods of sampling and analysis used for this purpose
can have direct repercussions on the establishment and functioning ofthe common market; whereas they should, therefore, be harmonized;
Whereas the laying down of these methods of sampling and analysis
constitutes a measure of a purely scientific and technical nature;whereas a rapid procedure for developing, improving and supple-menting such methods is necessary; whereas, in order to facilitate theadoption of suchmeasures, a procedure sh ould be introduced for close
cooperation between the Member States and the Commission within
the Standing Committee for Foodstuffs,
HAS ADOPTED THIS DIRECTIVE:
Article 1
1. Where it is necessary to introduce Community methods of
sampling or analysis for the purpose of determining the composition,conditions of manufacture, packaging or labelling of a foodstuff, suchmethods shall be adopted by the Commission or by the Council asappropriate in accordance withth e procedure laid down in Article 4.
2. Paragraph 1 shall be without prejudice to any specific provisions
currently in force or hereafter adopted in the context of specialCommunity rules.
3. For the purposes of determining whether it is necessary to intro-
duce the measures provided for in paragraph 1, the following criteria inparticular will be taken into consideration:
(a) the need to ensure that Community law is uniformly applied;
(b) the existence of barriers to intra-Community trade;
(c) the permanent or recurrent nature of the criteria referred to in (a) or
(b).
Article 2
1. The Directives provided for in Article 1 shall take account of the
state of scientific and technical knowledge, in particular of provenmethods of sampling and analysis.1985L0591 — EN — 20.11.2003 — 001.001 — 2
(1) OJ No C 53, 24. 2. 1984, p. 9.
(2) OJ No C 46, 18. 2. 1985, p. 95.
(3) OJ No C 44, 15. 2. 1985, p. 1.
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2. SuchDirectives sh all specify appropriate time limits for Member
States to implement them.
3. The introduction of the measures provided for in Article 1 (1)
shall not preclude Member States from using other tested and scientifi-cally valid methods provided that this does not hinder the freemovement of products recognized as complying withth e rules byvirtue of Community methods. However, in the event of differences in
the interpretation of results, those obtained by the use of Community
methods shall be determinant.
4. The methods of analysis introduced shall comply with the criteria
set out in the Annex.
5. Without prejudice to Article 3, the necesaary amendments to
existing Directives in so far as appropriate in view of the advancedstate of scientific and technological knowledge may, at the request ofa Member State, be adopted by means of the procedure provided forin Article 4.
Article 3
1. Where a Member State has detailed evidence that a measure
adopted in accordance withArticle 1 is inappropriate in a particularcase for technical reasons or because it is insufficiently conclusive forthe examination of an important health question, that Member State
may temporarily suspend the measure in question in its territory but
only for that particular case. It shall immediately inform the otherMember States and the Commission thereof and give reasons for itsdecision.
2. The Commission shall examine as soon as possible the evidence
given by the Member State and then consult the Member States within
the Standing Committee for Foodstuffs referred to in Article 4, afterwhich it shall deliver its opinion forthwith and take the appropriatemeasures.
3. If the Commission considers that amendments to the measure
adopted in accordance withArticle 1 are necessary in order to resolve
the difficulties mentioned in paragraph 1, it shall initiate the procedurelaid down in Article 4. The member State which has suspended theCommunity measure may, in that event, continue to do so until theamendments enter into force.
Article 4
1. The Commission shall be assisted by the Standing Committee on
the Food Chain and Animal Health, set up by Article 58 of Regulation
(EC) No 178/2002 (
1), hereinafter referred to as ‘the Committee’.
2. Where reference is made to this Article, Articles 5 and 7 of Deci-
sion 1999/468/EC (2) shall apply, having regard to the provisions of
Article 8 thereof.
The period laid down in Article 5(6) of Decision 1999/468/EC shall be
set at three months.
3. The Committee shall adopt its rules of procedure.
Article 5
Member States shall, within a period of two years following notifica-
tion thereof (3), bring into force by law, regulation or administrative1985L0591 — EN — 20.11.2003 — 001.001 — 3
(1) OJ L 31, 1.2.2002, p. 1.
(2) Council Decision 1999/468/EC of 28 June 1999 laying down the procedures
for the exercise of implementing powers conferred on the Commission (OJ
L 184, 17.7.1999, p. 23).
(3) This Directive was notified to the Member States on 23 December 1985.▼M1
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action any provisions necessary to comply with this Directive. They
shall forthwith inform the Commission thereof.
Article 6
This Directive is addressed to the Member States.1985L0591 — EN — 20.11.2003 — 001.001 — 4
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ANNEX
1. Methods of analysis which are to be considered for adoption under the provi-
sions of the Directive shall be examined with respect to the following
criteria:
(i) specificity,
(ii) accuracy,
(iii) precision; repeatability intra-laboratory (within laboratory) and reprodu-
cibility interlaboratory (within and between laboratories) variabilities,
(iv) limit of detection,
(v) sensitivity,
(vi) practicability and applicability,
(vii) other criteria which may be selected as required.
2. The precision values referred to in 1 (iii) shall be obtained from a collabora-
tive trial which has been conducted in accordance with an internationally
recognized protocol on collaborative trials (e.g. International Organization
of Standarization ‘Precision of Test Methods’ (ISO 5725/1981)). The repeat-
ability and reproducibility values shall be expressed in an internationally
recognized form (e.g. the 95 % confidence intervals as defined by ISO
5725/1981). The results from the collaborative trial shall be published or
freely available.
3. Methods of analysis which are applicable uniformly to various groups of
commodities should be given preference over methods which apply only to
individual commodities.
4. Methods of analysis adopted under this Directive should be edited in the
standard layout for methods of analysis recommended by the International
Organization for Standardization.1985L0591 — EN — 20.11.2003 — 001.001 — 5