Council Directive 89/109/EEC of 21 December 1988 on the approximation of the laws of the Member States relating to materials and articles intended to come into contact with foodstuffs
Date: 1988-12-21
Institutions: Council of the European Union
Subjects: approximation of laws, foodstuff, labelling, marketing, packaging product, preparation for market













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31989L0109

Council Directive 89/109/EEC of 21 December 1988 on the approximation of the laws of the Member States relating to materials and articles intended to come into contact with foodstuffs  


Official Journal L 040 , 11/02/1989 P. 0038 - 0044 Finnish special edition: Chapter 13 Volume 17 P. 0207  Swedish special edition: Chapter 13 Volume 17 P. 0207  





COUNCIL DIRECTIVEof 21 December 1988on the approximation  of the laws of the Member States relating to materials and articles intended to come into contact  with foodstuffs(89/109/EEC)THE COUNCIL OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Economic Community, and in particular Article  l00a thereof, Having regard to the Proposal from the Commission, In cooperation with the European Parliament (1), Having regard to the opinion of the Economic and Social Committee (2), Whereas Council Directive 76/893/EEC of 23 November 1976 on the approximation of the laws of the  Member States relating to materials and articles intended to come into contact with foodstuffs (3),  as last amended by the act of Accession of Spain and Portugal (4), has been substantially amended  on a number of occasions; whereas on making the new amendments to the said Directive, the  opportunity should be taken to consolidate the provisions of the existing relevant texts with a  view to ensuring legal clarity; Whereas Directive 76/893/EEC was adopted on the grounds that the differences that existed at that  time between the national laws relating to the aforesaid materials and articles impeded the free  movement thereof, could create unequal conditions of competition and could thereby directly affect  the establishment or functioning of the common market; Whereas those laws had to be approximated if free movement was to be achieved for the aforesaid  materials and articles, taking account primarily of human health requirements but also, within the  limits required for the protection of health, of economic and technological needs; Whereas the chosen method was to lay down, in the first place, in a framework directive, general  principles on the basis of which legal differences between certain groups of materials and articles  had been and could subsequently beeliminated by means of specific directives; whereas this method  has proved itself and should therefore be retained; Whereas covering or coating substances, all or part of which form part of foodstuffs, could not  be considered to be simply in contact with these foodstuffs: whereas, in that case, account had to  be taken of possible direct consumption by consumers; whereas the rules laid down in this Directive  are therefore inappropriate in such circumstances; Whereas the principle underlying this Directive should be that any material or article intended to  come into contact or which is intentionally in contact either directly or indirectly with  foodstuffs, must be sufficiently stable not to transfer substances to the foodstuffs in quantities  which could endanger human health or bring about an unacceptable change in the composition of the  foodstuffs or a deterioration in the organoleptic properties thereof; Whereas, in order to achieve this objective, it may prove necessary to lay down various types of  limitations, alone or in combination; whereas it is appropriate to retain in specific directives  those limitations which are most appropriate to the desired objective, having regard to the  technological characteristics peculiar to each group of materials and articles; Whereas, in order to allow the informed use of the materials and articles, appropriate labelling  should be provided for; whereas the methods used for such labelling may vary according to the  user; Whereas this Directive does not apply to the labelling of products which, by reason of their  behaviour in the presence of foodstuffs, must not be designed to come into contact or be in contact  with them; Whereas the drafting of specific directives implementing the basic principles and of amendments  thereto constitute technical implementing measures; whereas, in order to simplify and expedite the  procedure, the adoption of these measures should be entrusted to the Commission; Whereas the Scientific Committee for Food, set up by Commission Decision 74/234/EEC (5), should be  asked for its opinion before provisions liable to affect public health are adopted under specific  directives; Whereas it is desirable that in all cases where the Council empowers the Commission to implement  rules relating to foodstuffs, provision should be made for a procedure establishing close  cooperation between the Member States and the Commission within the Standing Committee on  Foodstuffs set up by Council Decision 69/414/EEC (1)HAS ADOPTED THIS DIRECTIVE: Article 11. This Directive shall apply to materials and articles which, in  their finished state, are intended to be brought into contact with foodstuffs or which are brought  into contact with foodstuffs and are intended for that purpose, hereinafter referred ro as  'materials and articles'. Covering or coating substances, such as the substances convering cheese rinds, prepared meat  products or fruit, which form part of foodstuffs and may be consumed together with those  foodstuffs, shall not be subject to this Directive2. This Directive shall apply to materials and  articles which are in contact with water which is intended for human consumption. It shall not,  however, apply to fixed public or private water supply equipment. 3. This Directive shall not apply to antiques. Article 2Materials and articles must be manufactured in compliance with good manufacturing  practice so that, under their normal or foreseeable conditions of use, they do not transfer their  constituents to foodstuffs in quantities which could: - endanger human health, - bring about an unacceptable change in the composition of the foodstuffs or a deterioration in the  organoleptic characteristics thereof. Article 31. The groups of materials and articles listed in Amex I and, where appropriate,  combinations of these materials and articles shall be subject to specific directives. 2. The specific directives, including amendments to existing specific directives, shall be adopted  in accordance with the procedure laid down in Article 8. 3. The specific directives may include: (a) a list of the substances the use of which is authorized to the exclusion of all others  (positive list); (b) purity standards for such substances; (c) special conditions of use for these substances and/or the materials and articles in which they  are used; (d) specific limits on the migration of certain constituents or groups of constituents into or onto  foodstuffs: (e) an overall limit on the migration of constituents into or outo foodstuffs; (f) if necessary, provisions aimed at protecting human health against any hazards which might arise  through oral contact with materials and articles; (g) other rules to ensure compliance with Article 2; (h) the basic rules necessary for checking compliance with the provisions of points (d), (e), (f)  and (g); (i) detailed rles concerning sample taking and the methods of analysis required to check compliance  with the provisions of points (a) to (g). provisions liable to affect public health shall be adopted after consulting the Scientific  Committee for Food. They must fulfill the criteria set out in Annex II. Article 41. Notwithstanding Article 3, a Member State may, where a list of substances has been  drawn up in accordance with paragraph 3 (a) of that Article, authorize the use within its territory  of a substance not included in the list, subject to compliance with the following conditions: (a) the authorization must be limited to a maximum period of two years; (b) the Member State must carry out an official check on materials and articles manufactured from a  substance of which it has authorized the use; (c) materials and articles thus manufactured must bear a distinctive indication which will be  defined in the authorization. 2. The Member State shall forward to the other Member States and to the Commission the text of any  authorization drawn up pursuant to paragraph 1 within two months of the date of its taking effect. 3. Before the expiry of the two-year period provided for in paragraph 1 (a), the Member State may  submit to the Commission a request for the inclusion in the list referred to. in Article 3 (3) (a) of the substance given national authorization in accordance with paragraph 1  of this Article. At the same time, it shall supply supporting documents setting out the grounds on  which it deems such inclusion justified and shall indicate the uses for which this substance is  ineendedWithin 18 months of the submission of the request, a decision shall be taken on the basis  of information relating to public health, after consulting the Scientific Committee for Food and in  accordance with the procedure laid down in Article 9 as to whether the substance in question may be  included in the list referred to in Article 3 (a) or whether the national authorization should be  revoked. If provisions prove necessary pursuant to Article 3 (3) (b), (c) and (d), these shall be  adopted in accordance with the same procedure. Notwithstanding paragraph 1 (a) of this Article, the  national authorization shall remain in force until a decision is taken on the request for inclusion  in the list. Should it be decided pursuant to the preceding subparagraph that the national authorization should  be revoked, this decision shall apply to any other national authorization in respect of the  substance in question. The decision may stipulate that the ban on the use of this substance shall  extend to uses other than those referred to in the request for inclusion in the list. Article 51. Where a Member State, as a result of new information or of a reassessment of existing  information made since one of the specific directives was adopted, has detailed grounds for  establishing that the use of a material or article endangers human health although it complies with  the relevant specific directive, that Member State may temporarily suspend or restrict application  of the provisions in question within its territory. It shall immediately inform the other Member  States and the Commission thereof and give reasons for its decision2. The Commission shall examine  as soon as possible within the Standing Committee on Foodstuffs the grounds adduced by the Member  State referred to in Paragraph 1 and shall deliver its opinion without delay and take the  appropriate measures. 3. If the Commission considers that amendments to the specific directives in question are necessary  in order to remedy the difficulties mentioned in paragraph 1 and to ensure the protection of human  health, it shall initiate the procedure laid down in Article 9 with a view to adopting those  amendments; the Member State which has adopted safeguard measures may in that event retain them  until the amendments have been adopted. Article 61. Without prejudice to any exceptions provided for in the specific directives,  materials and articles not already in contact with foodstuffs must, when placed on the market, be  accompanied by: (a) - the words 'for food use', - or a specific indication as to their use, such as coffee-machine, wine bottle, soup spoon, - or a symbol determined in accordance with the procedure laid down in Article 9; (b) where appropriate, any special conditions to be observed when they are being used: (c) - either the name or trade name and the address or registered office, - or the registered trade mark, of the manufacturer or processor, or of a seller established within the Community. 2. The particulars listed in paragraph 1 must be conspicuous, clearly legible and indelible: (a) at the retail stage: - on the materials and articles or on the packaging, - or on labels affixed to the materials and articles or to their packaging, - or on a notice in the immediate vicinity of the materials and articles and clearly visible to  purchasers; in the case mentioned in paragraph 1 (e), however, the latter option shall only be open  if these particulars or a label bearing them cannot, for technical reasons, be affixed to the said  materials and articles at either the manufacturing or the marketing stage; (b) at the marketing stages other than the retail stage: - on the accompanying documents, - on the labels or packaging, - or on the materials and articles themselves. 3. However, the particulars provided for in paragraph 1 shall not be compulsory for materials and  articles which by their nature are clearly intended to come into contact with foodstuffs. 4. The particulars provided for in paragraph 1 (a) and (b) shall be confined to materials and  articles which comply: (a) with the criteria laid down in Article 2; (b) with the specific directives, in the absence of such directives, with any national provisions. 5. The specific directives shall require that such materials and articles be accompanied by a  written declaration attesting that they comply with the rules applicable to them. In the absence of specific directives, Member States may retain existing provisions or adopt  provisions to this effect. 6. Member States shall ensure that retail trade in materials and articles is prohibited if the  particulars required under paragraph 1 (a) and (b) are not given in a language easily understood by  purchasers, unless the purchaser is informed by other means. This provision shall not preclude such  particulars appearing in several languages. Article 71. Member States shall not, for reasons relating to composition, behaviour in the  presence of foodstuffs or labelling, prohibit or restrict either trade in or the use of materials  and articles complying with this Directive or with the specific directives. 2. Paragraph 1 shall not affect national provisions which are applicable in the absence of the  specific directives. Article 8Amendments made to existing specific directives in order to bring them into line with  this Directive shall be adopted in accordance with the procedure laid down in Article 9. Article 91. Where the procedure laid down in this Article is to be followed, the chairman shall  refer the matter to the Standing Committee on Foodstuffs either on his own initiative or at the  request of the representative of a Member State. 2. The Commission representative shall submit to the committee a draft of measures to be taken. The  committee shall deliver its opinion on the draft within a time limit which the chairman may lay  down according to the urgency of the matter. The opinion shall be delivered by the qualified  majority laid down in Article 148 (2) of the Treaty. The chairman shall not vote. 3. (a) The Commission shall adopt the intended measures when they are in accordance with the  committee's opinion; (b) where the intended measures are not in accordance with the opinion of the committee, or in the  absence of any opinion, the Commission shall forthwith submit to the Council a proposal relating to  the measures to be taken. The Council shall act on a qualified majority. If, on the expiry of three months from the date on which the matter was referred to it, the Council  has not adopted any measures, the Commission shall adopt the proposed measures and apply them  immediately. Article 101. Directive 76/893/EEC is hereby repealed2. References to the Directive repealed  under paragraph 1 shall be construed as references to this Directive. References to the Articles of the repealed Directive should be read in accordance with the  correlation table appearing in Annex III. Article 111. Member States shall take all measures necessary to comply with this Directive. They  shall forthwith inform the Commission thereof. He measures taken shall: - permit, not later than 18 months after notification (1), trade in and use of materials and  articles complying with this Directive, without prejudice to the application of national provisions  which, in the absence of specific directives, apply to certain groups of materials and articles; - prohibit not later than 36 months after notification trade in and use of materials and articles  which do not comply with this Directive. 2. Paragraph 1 shall not affect those national provisions which, in the absence of the specific  directives, apply to certain groups of materials and articles intended to come into contact with  foodstuffs. Article 12This Directive shall not apply to materials and articles intended for export outside  the Community. Article 13This Directive is addressed to the Member States. Done at Brussels, 21 December 1988. For the Council The PresidentV. PAPANDREOU(1) This Directive was notified to the Member States  on 10 January 1989(1) OJ N° C 99, 13. 4. 1987, p. 65 and OJ N° C 12, 16.  1989. (2) OJ N° C 328, 22. 12. 1986, p. 5. (3) OJ N° L 340, 9. 12. 1976, p. 19. (4) OJ N° L 302, 15. 11. 1985, p. 216. (5) OJ N° L 136, 20. 5. 1974, p. 1. (1) OJ N° L. 291, 19. 11. 1969, p. 9  ANNEX I List of groups of materials and articles covered by specific directives  Plastics, including varnish and coatingsRegenerated celluloseElastomers and rubberPaperand  boardCeramicsGlassMetals and alloysWood, including corkTextile productsParaffin waxes and  micro-cystalline waxes ANNEX II Health criteria to be applied in the drafting of specific directives 1. Where  appropriate, Positive lists of substances shall be established for materials and articles intended  to come into contact with foodstuffs. The acceptability of a substance for inclusion in a positive  list shall be determined by considering both the quantity of the substance which is liable to  migrate into foodstuffs and the toxicity of the substance2. A substance shall only be included in  a positive list where, under normal or foreseeable conditions of use of any material or article of  which it forms a part, the substance is not liable to migrate into foodstuffs in a quantity likely  to constitute a danger to human health3. For certain materials it may be inappropriate to  establish a positive list because such a list would offer no tangible benefit in terms of  safeguarding human health. In such circumstances, any substances for which specific migration  limits need to be established in order to prevent their being transferred to foodstuffs in  quantities likely to constitute a danger to health shall be identified. The criteria set out in  paragraphs 1 and 2 shall also apply to these substances4. All substances shall be kept under  review and reassessed whenever this is justified by fresh scientific data or a re-evaluation of  existing scientific data5. Where an acceptable daily intake or a tolerable daily intake is  established foraparticular substance, the need to establish a specific migration limit in order  that this intake is not exceeded shall be considered. Where such a specific migration limit is  established for a substance, due regard shall be paid to other possible sources of exposure to the  substance6. In certain circumstances, a specific migration limit on a substance may not be the  most valid means of safeguarding human health. In such circumstances, the need to protect human  health shall be the primary consideration in determining what action might be appropriate. ANNEX III CORRELATION TABLF >TABLE>