28.10.1998 EN Official Journal of the European Communities L 289/28 DIRECTIVE 98/71/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 13 October 1998 on the legal protection of designs THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community and in particular Article 100a thereof, Having regard to the proposal by the Commission (1), Having regard to the opinion of the Economic and Social Committee (2), Acting in accordance with the procedure laid down in Article 189b of the Treaty (3), in the light of the joint text approved by the Conciliation Committee on 29 July 1998, (1) Whereas the objectives of the Community, as laid down in the Treaty, include laying the foundations of an ever closer union among the peoples of Europe, fostering closer relations between Member States of the Community, and ensuring the economic and social progress of the Community countries by common action to eliminate the barriers which divide Europe; whereas to that end the Treaty provides for the establishment of an internal market characterised by the abolition of obstacles to the free movement of goods and also for the institution of a system ensuring that competition in the internal market is not distorted; whereas an approximation of the laws of the Member States on the legal protection of designs would further those objectives; (2) Whereas the differences in the legal protection of designs offered by the legislation of the Member States directly affect the establishment and functioning of the internal market as regards goods embodying designs; whereas such differences can distort competition within the internal market; (3) Whereas it is therefore necessary for the smooth functioning of the internal market to approximate the design protection laws of the Member States; (4) Whereas, in doing so, it is important to take into consideration the solutions and the advantages with which the Community design system will provide undertakings wishing to acquire design rights; (5) Whereas it is unnecessary to undertake a full-scale approximation of the design laws of the Member States, and it will be sufficient if approximation is limited to those national provisions of law which most directly affect the functioning of the internal market; whereas provisions on sanctions, remedies and enforcement should be left to national law; whereas the objectives of this limited approximation cannot be sufficiently achieved by the Member States acting alone; (6) Whereas Member States should accordingly remain free to fix the procedural provisions concerning registration, renewal and invalidation of design rights and provisions concerning the effects of such invalidity; (7) Whereas this Directive does not exclude the application to designs of national or Community legislation providing for protection other than that conferred by registration or publication as design, such as legislation relating to unregistered design rights, trade marks, patents and utility models, unfair competition or civil liability; (8) Whereas, in the absence of harmonisation of copyright law, it is important to establish the principle of cumulation of protection under specific registered design protection law and under copyright law, whilst leaving Member States free to establish the extent of copyright protection and the conditions under which such protection is conferred; (9) Whereas the attainment of the objectives of the internal market requires that the conditions for obtaining a registered design right be identical in all the Member States; whereas to that end it is necessary to give a unitary definition of the notion of design and of the requirements as to novelty and individual character with which registered design rights must comply; (10) Whereas it is essential, in order to facilitate the free movement of goods, to ensure in principle that registered design rights confer upon the right holder equivalent protection in all Member States; (11) Whereas protection is conferred by way of registration upon the right holder for those design features of a product, in whole or in part, which are shown visibly in an application and made available to the public by way of publication or consultation of the relevant file; (12) Whereas protection should not be extended to those component parts which are not visible during normal use of a product, or to those features of such part which are not visible when the part is mounted, or which would not, in themselves, fulfil the requirements as to novelty and individual character; whereas features of design which are excluded from protection for these reasons should not be taken into consideration for the purpose of assessing whether other features of the design fulfil the requirements for protection; (13) Whereas the assessment as to whether a design has individual character should be based on whether the overall impression produced on an informed user viewing the design clearly differs from that produced on him by the existing design corpus, taking into consideration the nature of the product to which the design is applied or in which it is incorporated, and in particular the industrial sector to which it belongs and the degree of freedom of the designer in developing the design; (14) Whereas technological innovation should not be hampered by granting design protection to features dictated solely by a technical function; whereas it is understood that this does not entail that a design must have an aesthetic quality; whereas, likewise, the interoperability of products of different makes should not be hindered by extending protection to the design of mechanical fittings; whereas features of a design which are excluded from protection for these reasons should not be taken into consideration for the purpose of assessing whether other features of the design fulfil the requirements for protection; (15) Whereas the mechanical fittings of modular products may nevertheless constitute an important element of the innovative characteristics of modular products and present a major marketing asset and therefore should be eligible for protection; (16) Whereas a design right shall not subsist in a design which is contrary to public policy or to accepted principles of morality; whereas this Directive does not constitute a harmonisation of national concepts of public policy or accepted principles of morality; (17) Whereas it is fundamental for the smooth functioning of the internal market to unify the term of protection afforded by registered design rights; (18) Whereas the provisions of this Directive are without prejudice to the application of the competition rules under Articles 85 and 86 of the Treaty; (19) Whereas the rapid adoption of this Directive has become a matter of urgency for a number of industrial sectors; whereas full-scale approximation of the laws of the Member States on the use of protected designs for the purpose of permitting the repair of a complex product so as to restore its original appearance, where the product incorporating the design or to which the design is applied constitutes a component part of a complex product upon whose appearance the protected design is dependent, cannot be introduced at the present stage; whereas the lack of full-scale approximation of the laws of the Member States on the use of protected designs for such repair of a complex product should not constitute an obstacle to the approximation of those other national provisions of design law which most directly affect the functioning of the internal market; whereas for this reason Member States should in the meantime maintain in force any provisions in conformity with the Treaty relating to the use of the design of a component part used for the purpose of the repair of a complex product so as to restore its original appearance, or, if they introduce any new provisions relating to such use, the purpose of these provisions should be only to liberalise the market in such parts; whereas those Member States which, on the date of entry into force of this Directive, do not provide for protection for designs of component parts are not required to introduce registration of designs for such parts; whereas three years after the implementation date the Commission should submit an analysis of the consequences of the provisions of this Directive for Community industry, for consumers, for competition and for the functioning of the internal market; whereas, in respect of component parts of complex products, the analysis should, in particular, consider harmonisation on the basis of possible options, including a remuneration system and a limited term of exclusivity; whereas, at the latest one year after the submission of its analysis, the Commission should, after consultation with the parties most affected, propose to the European Parliament and the Council any changes to this Directive needed to complete the internal market in respect of component parts of complex products, and any other changes which it considers necessary; (20) Whereas the transitional provision in Article 14 concerning the design of a component part used for the purpose of the repair of a complex product so as to restore its original appearance is in no case to be construed as constituting an obstacle to the free movement of a product which constitutes such a component part; (21) Whereas the substantive grounds for refusal of registration in those Member States which provide for substantive examination of applications prior to registration, and the substantive grounds for the invalidation of registered design rights in all the Member States, must be exhaustively enumerated, HAVE ADOPTED THIS DIRECTIVE: Article 1 Definitions For the purpose of this Directive: (a) ‘design’ means the appearance of the whole or a part of a product resulting from the features of, in particular, the lines, contours, colours, shape, texture and/or materials of the product itself and/or its ornamentation; (b) ‘product’ means any industrial or handicraft item, including inter alia parts intended to be assembled into a complex product, packaging, get-up, graphic symbols and typographic typefaces, but excluding computer programs; (c) ‘complex product’ means a product which is composed of multiple components which can be replaced permitting disassembly and reassembly of the product. Article 2 Scope of application 1. This Directive shall apply to: (a) design rights registered with the central industrial property offices of the Member States; (b) design rights registered at the Benelux Design Office; (c) design rights registered under international arrangements which have effect in a Member State; (d) applications for design rights referred to under (a), (b) and (c). 2. For the purpose of this Directive, design registration shall also comprise the publication following filing of the design with the industrial property office of a Member State in which such publication has the effect of bringing a design right into existence. Article 3 Protection requirements 1. Member States shall protect designs by registration, and shall confer exclusive rights upon their holders in accordance with the provisions of this Directive. 2. A design shall be protected by a design right to the extent that it is new and has individual character. 3. A design applied to or incorporated in a product which constitutes a component part of a complex product shall only be considered to be new and to have individual character: (a) if the component part, once it has been incorporated into the complex product, remains visible during normal use of the latter, and (b) to the extent that those visible features of the component part fulfil in themselves the requirements as to novelty and individual character. 4. ‘Normal use’ within the meaning of paragraph (3)(a) shall mean use by the end user, excluding maintenance, servicing or repair work. Article 4 Novelty A design shall be considered new if no identical design has been made available to the public before the date of filing of the application for registration or, if priority is claimed, the date of priority. Designs shall be deemed to be identical if their features differ only in immaterial details. Article 5 Individual character 1. A design shall be considered to have individual character if the overall impression it produces on the informed user differs from the overall impression produced on such a user by any design which has been made available to the public before the date of filing of the application for registration or, if priority is claimed, the date of priority. 2. In assessing individual character, the degree of freedom of the designer in developing the design shall be taken into consideration. Article 6 Disclosure 1. For the purpose of applying Articles 4 and 5, a design shall be deemed to have been made available to the public if it has been published following registration or otherwise, or exhibited, used in trade or otherwise disclosed, except where these events could not reasonably have become known in the normal course of business to the circles specialised in the sector concerned, operating within the Community, before the date of filing of the application for registration or, if priority is claimed, the date of priority. The design shall not, however, be deemed to have been made available to the public for the sole reason that it has been disclosed to a third person under explicit or implicit conditions of confidentiality. 2. A disclosure shall not be taken into consideration for the purpose of applying Articles 4 and 5 if a design for which protection is claimed under a registered design right of a Member State has been made available to the public: (a) by the designer, his successor in title, or a third person as a result of information provided or action taken by the designer, or his successor in title; and (b) during the 12-month period preceding the date of filing of the application or, if priority is claimed, the date of priority. 3. Paragraph 2 shall also apply if the design has been made available to the public as a consequence of an abuse in relation to the designer or his successor in title. Article 7 Designs dictated by their technical function and designs of interconnections 1. A design right shall not subsist in features of appearance of a product which are solely dictated by its technical function. 2. A design right shall not subsist in features of appearance of a product which must necessarily be reproduced in their exact form and dimensions in order to permit the product in which the design is incorporated or to which it is applied to be mechanically connected to or placed in, around or against another product so that either product may perform its function. 3. Notwithstanding paragraph 2, a design right shall, under the conditions set out in Articles 4 and 5, subsist in a design serving the purpose of allowing multiple assembly or connection of mutually interchangeable products within a modular system. Article 8 Designs contrary to public policy or morality A design right shall not subsist in a design which is contrary to public policy or to accepted principles of morality. Article 9 Scope of protection 1. The scope of the protection conferred by a design right shall include any design which does not produce on the informed user a different overall impression. 2. In assessing the scope of protection, the degree of freedom of the designer in developing his design shall be taken into consideration. Article 10 Term of protection Upon registration, a design which meets the requirements of Article 3(2) shall be protected by a design right for one or more periods of five years from the date of filing of the application. The right holder may have the term of protection renewed for one or more periods of five years each, up to a total term of 25 years from the date of filing. Article 11 Invalidity or refusal of registration 1. A design shall be refused registration, or, if the design has been registered, the design right shall be declared invalid: (a) if the design is not a design within the meaning of Article l(a); or (b) if it does not fulfil the requirements of Articles 3 to 8; or (c) if the applicant for or the holder of the design right is not entitled to it under the law of the Member State concerned; or (d) if the design is in conflict with a prior design which has been made available to the public after the date of filing of the application or, if priority is claimed, the date of priority, and which is protected from a date prior to the said date by a registered Community design or an application for a registered Community design or by a design right of the Member State concerned, or by an application for such a right. 2. Any Member State may provide that a design shall be refused registration, or, if the design has been registered, that the design right shall be declared invalid: (a) if a distinctive sign is used in a subsequent design, and Community law or the law of the Member State concerned governing that sign confers on the right holder of the sign the right to prohibit such use; or (b) if the design constitutes an unauthorised use of a work protected under the copyright law of the Member State concerned; or (c) if the design constitutes an improper use of any of the items listed in Article 6b of the Paris Convention for the Protection of Industrial Property, or of badges, emblems and escutcheons other than those covered by Article 6b of the said Convention which are of particular public interest in the Member State concerned. 3. The ground provided for in paragraph 1(c) may be invoked solely by the person who is entitled to the design right under the law of the Member State concerned. 4. The grounds provided for in paragraph 1(d) and in paragraph 2(a) and (b) may be invoked solely by the applicant for or the holder of the conflicting right. 5. The ground provided for in paragraph 2(c) may be invoked solely by the person or entity concerned by the use. 6. Paragraphs 4 and 5 shall be without prejudice to the freedom of Member States to provide that the grounds provided for in paragraphs 1(d) and 2(c) may also be invoked by the appropriate authority of the Member State in question on its own initiative. 7. When a design has been refused registration or a design right has been declared invalid pursuant to paragraph 1(b) or to paragraph 2, the design may be registered or the design right maintained in an amended form, if in that form it complies with the requirements for protection and the identity of the design is retained. Registration or maintenance in an amended form may include registration accompanied by a partial disclaimer by the holder of the design right or entry in the design Register of a court decision declaring the partial invalidity of the design right. 8. Any Member State may provide that, by way of derogation from paragraphs 1 to 7, the grounds for refusal of registration or for invalidation in force in that State prior to the date on which the provisions necessary to comply with this Directive enter into force shall apply to design applications which have been made prior to that date and to resulting registrations. 9. A design right may be declared invalid even after it has lapsed or has been surrendered. Article 12 Rights conferred by the design right 1. The registration of a design shall confer on its holder the exclusive right to use it and to prevent any third party not having his consent from using it. The aforementioned use shall cover, in particular, the making, offering, putting on the market, importing, exporting or using of a product in which the design is incorporated or to which it is applied, or stocking such a product for those purposes. 2. Where, under the law of a Member State, acts referred to in paragraph 1 could not be prevented before the date on which the provisions necessary to comply with this Directive entered into force, the rights conferred by the design right may not be invoked to prevent continuation of such acts by any person who had begun such acts prior to that date. Article 13 Limitation of the rights conferred by the design right 1. The rights conferred by a design right upon registration shall not be exercised in respect of: (a) acts done privately and for non-commercial purposes; (b) acts done for experimental purposes; (c) acts of reproduction for the purposes of making citations or of teaching, provided that such acts are compatible with fair trade practice and do not unduly prejudice the normal exploitation of the design, and that mention is made of the source. 2. In addition, the rights conferred by a design right upon registration shall not be exercised in respect of: (a) the equipment on ships and aircraft registered in another country when these temporarily enter the territory of the Member State concerned; (b) the importation in the Member State concerned of spare parts and accessories for the purpose of repairing such craft; (c) the execution of repairs on such craft. Article 14 Transitional provision Until such time as amendments to this Directive are adopted on a proposal from the Commission in accordance with the provisions of Article 18, Member States shall maintain in force their existing legal provisions relating to the use of the design of a component part used for the purpose of the repair of a complex product so as to restore its original appearance and shall introduce changes to those provisions only if the purpose is to liberalise the market for such parts. Article 15 Exhaustion of rights The rights conferred by a design right upon registration shall not extend to acts relating to a product in which a design included within the scope of protection of the design right is incorporated or to which it is applied, when the product has been put on the market in the Community by the holder of the design right or with his consent. Article 16 Relationship to other forms of protection The provisions of this Directive shall be without prejudice to any provisions of Community law or of the law of the Member State concerned relating to unregistered design rights, trade marks or other distinctive signs, patents and utility models, typefaces, civil liability or unfair competition. Article 17 Relationship to copyright A design protected by a design right registered in or in respect of a Member State in accordance with this Directive shall also be eligible for protection under the law of copyright of that State as from the date on which the design was created or fixed in any form. The extent to which, and the conditions under which, such a protection is conferred, including the level of originality required, shall be determined by each Member State. Article 18 Revision Three years after the implementation date specified in Article 19, the Commission shall submit an analysis of the consequences of the provisions of this Directive for Community industry, in particular the industrial sectors which are most affected, particularly manufacturers of complex products and component parts, for consumers, for competition and for the functioning of the internal market. At the latest one year later the Commission shall propose to the European Parliament and the Council any changes to this Directive needed to complete the internal market in respect of component parts of complex products and any other changes which it considers necessary in light of its consultations with the parties most affected. Article 19 Implementation 1. Member States shall bring into force the laws, regulations or administrative provisions necessary to comply with this Directive not later than 28 October 2001. When Member States adopt these provisions, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. 2. Member States shall communicate to the Commission the provisions of national law which they adopt in the field governed by this Directive. Article 20 Entry into force This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities. Article 21 Addressees This Directive is addressed to the Member States. Done at Luxembourg, 13 October 1998. For the European Parliament The President J. M. GIL-ROBLES For the Council The President C. EINEM (1) OJ C 345, 23. 12. 1993, p. 14 and OJ C 142, 14. 5. 1996, p. 7. (2) OJ C 388, 31. 12. 1994, p. 9 and OJ C 110, 2. 5. 1995, p. 12. (3) Opinion of the European Parliament of 12 October 1995 (OJ C 287, 30. 10. 1995, p. 157), common position of the Council of 17 June 1997 (OJ C 237, 4. 8. 1997, p. 1), Decision of the European Parliament of 22 October 1997 (OJ C 339, 10. 11. 1997, p. 52). Decision of the European Parliament of 15 September 1998. Decision of the Council of 24 September 1998. Statement by the Commission The Commission shares the European Parliament's concern about combating counterfeiting. The Commission's intention is to present before the end of the year a Green Paper regarding piracy and counterfeiting in the internal market. The Commission will include in this Green Paper Parliament's idea of creating an obligation for counterfeiters to provide holders of design rights with information on their illegal acts. Statement by the Commission regarding Article 18 Immediately following the date of adoption of the Directive, and without prejudice to Article 18, the Commission proposes to launch a consultation exercise involving manufacturers of complex products and of component parts in the motor vehicles sector. The aim of this consultation will be to arrive at a voluntary agreement between the parties involved on the protection of designs in cases where the product incorporating the design or to which the design is applied constitutes a component part of a complex product upon whose appearance the protected design is dependent. The Commission will coordinate the consultation exercise and will report regularly to the Parliament and the Council on its progress. The consulted parties will be invited by the Commission to consider a range of possible options on which to base a voluntary agreement, including a remuneration system and a system based on a limited period of design protection.

Summary: Harmonised national laws on the protection of designs Harmonised national laws on the protection of designs SUMMARY OF: Directive 98/71/EC ensuring the protection of industrial designs WHAT IS THE AIM OF THE DIRECTIVE? It aims to harmonise national laws on the protection of design to ensure the right holder has the same protection in all EU countries. National laws exist alongside an EU-wide system for obtaining a Community design covered by uniform protection. KEY POINTS The directive applies to design* rights registered: at the EU’s central industrial property offices; at the Benelux Office; under international agreements which have effect in an EU country. Conditions of protection To qualify for protection, a design has to be new and have an individual character. EU countries protect designs by registering them and conferring exclusive rights on their designers. Term of protection The design is protected for one or more periods of 5 years, with a maximum duration of 25 years. The protection confers on the holder the exclusive right to use the design and to prevent any third party from using it. Rights conferred by registration The registration of a design shall confer on its holder the exclusive right to use it and to prevent any unauthorised third party from using it. Restriction of rights The rights conferred by a design right do not extend to: acts done on a private basis and for non-commercial purposes; acts done for experimental purposes; acts of reproduction for illustrative or educational purposes; equipment on board ships and aircraft registered in another country when these temporarily enter the territory of the EU country concerned; importation into the EU country of spare parts and accessories for the purpose of repairing such craft; the execution of repairs on such craft. Also excluded from protection are: items incorporated into a product which are not visible during ‘normal’ use of this product; the characteristics of a product’s appearance which are solely dictated by its technical function; the characteristics of a product’s appearance which have to be reproduced in order to allow the product to be mechanically connected to, placed in or around, or in contact with another product; equipment on board ships and aircraft which temporarily enter the territory of another EU country; spare parts and accessories which are imported into that EU country for the purpose of repairing the aforementioned craft; designs which are contrary to public order or public morality. Invalidity A design right can be declared invalid, in certain defined cases, even after it has lapsed or has been surrendered (i.e. the right has been given up by the rights holder). Relationship with other forms of protection If, in an EU country, designs are protected by laws concerning unregistered designs, copyright, trademarks, patents and utility models or any other law, these laws still apply side by side with the specific legislation on the protection of designs. FROM WHEN DOES THE DIRECTIVE APPLY? It has applied since 17 November 1998. EU countries had to incorporate it into national law by 28 October 2001. BACKGROUND For more information, see: Industrial design protection * KEY TERMS Design: The appearance of all or part of a product resulting from the features of, in particular, the lines, contours, colours, shape, texture and/or materials of the product itself and/or its ornamentation. MAIN DOCUMENT Directive 98/71/EC of the European Parliament and of the Council of 13 October 1998 on the legal protection of designs (OJ L 289, 28.10.1998, pp. 28-35) RELATED ACTS Council Regulation (EC) No 6/2002 of 12 December 2001 on Community designs (OJ L 3, 5.1.2002, pp. 1-24) Successive amendments to Regulation (EC) No 6/2002 have been incorporated in the original text. This consolidated version is of documentary value only. last update 07.07.2016


30.7.1998 EN Official Journal of the European Communities L 213/13 DIRECTIVE 98/44/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 6 July 1998 on the legal protection of biotechnological inventions THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, and in particular Article 100a thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the Economic and Social Committee (2), Acting in accordance with the procedure laid down in Article 189b of the Treaty (3), (1) Whereas biotechnology and genetic engineering are playing an increasingly important role in a broad range of industries and the protection of biotechnological inventions will certainly be of fundamental importance for the Community's industrial development; (2) Whereas, in particular in the field of genetic engineering, research and development require a considerable amount of high-risk investment and therefore only adequate legal protection can make them profitable; (3) Whereas effective and harmonised protection throughout the Member States is essential in order to maintain and encourage investment in the field of biotechnology; (4) Whereas following the European Parliament's rejection of the joint text, approved by the Conciliation Committee, for a European Parliament and Council Directive on the legal protection of biotechnological inventions (4), the European Parliament and the Council have determined that the legal protection of biotechnological inventions requires clarification; (5) Whereas differences exist in the legal protection of biotechnological inventions offered by the laws and practices of the different Member States; whereas such differences could create barriers to trade and hence impede the proper functioning of the internal market; (6) Whereas such differences could well become greater as Member States adopt new and different legislation and administrative practices, or whereas national case-law interpreting such legislation develops differently; (7) Whereas uncoordinated development of national laws on the legal protection of biotechnological inventions in the Community could lead to further disincentives to trade, to the detriment of the industrial development of such inventions and of the smooth operation of the internal market; (8) Whereas legal protection of biotechnological inventions does not necessitate the creation of a separate body of law in place of the rules of national patent law; whereas the rules of national patent law remain the essential basis for the legal protection of biotechnological inventions given that they must be adapted or added to in certain specific respects in order to take adequate account of technological developments involving biological material which also fulfil the requirements for patentability; (9) Whereas in certain cases, such as the exclusion from patentability of plant and animal varieties and of essentially biological processes for the production of plants and animals, certain concepts in national laws based upon international patent and plant variety conventions have created uncertainty regarding the protection of biotechnological and certain microbiological inventions; whereas harmonisation is necessary to clarify the said uncertainty; (10) Whereas regard should be had to the potential of the development of biotechnology for the environment and in particular the utility of this technology for the development of methods of cultivation which are less polluting and more economical in their use of ground; whereas the patent system should be used to encourage research into, and the application of, such processes; (11) Whereas the development of biotechnology is important to developing countries, both in the field of health and combating major epidemics and endemic diseases and in that of combating hunger in the world; whereas the patent system should likewise be used to encourage research in these fields; whereas international procedures for the dissemination of such technology in the Third World and to the benefit of the population groups concerned should be promoted; (12) Whereas the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) (5) signed by the European Community and the Member States, has entered into force and provides that patent protection must be guaranteed for products and processes in all areas of technology; (13) Whereas the Community's legal framework for the protection of biotechnological inventions can be limited to laying down certain principles as they apply to the patentability of biological material as such, such principles being intended in particular to determine the difference between inventions and discoveries with regard to the patentability of certain elements of human origin, to the scope of protection conferred by a patent on a biotechnological invention, to the right to use a deposit mechanism in addition to written descriptions and lastly to the option of obtaining non-exclusive compulsory licences in respect of interdependence between plant varieties and inventions, and conversely; (14) Whereas a patent for invention does not authorise the holder to implement that invention, but merely entitles him to prohibit third parties from exploiting it for industrial and commercial purposes; whereas, consequently, substantive patent law cannot serve to replace or render superfluous national, European or international law which may impose restrictions or prohibitions or which concerns the monitoring of research and of the use or commercialisation of its results, notably from the point of view of the requirements of public health, safety, environmental protection, animal welfare, the preservation of genetic diversity and compliance with certain ethical standards; (15) Whereas no prohibition or exclusion exists in national or European patent law (Munich Convention) which precludes a priori the patentability of biological matter; (16) Whereas patent law must be applied so as to respect the fundamental principles safeguarding the dignity and integrity of the person; whereas it is important to assert the principle that the human body, at any stage in its formation or development, including germ cells, and the simple discovery of one of its elements or one of its products, including the sequence or partial sequence of a human gene, cannot be patented; whereas these principles are in line with the criteria of patentability proper to patent law, whereby a mere discovery cannot be patented; (17) Whereas significant progress in the treatment of diseases has already been made thanks to the existence of medicinal products derived from elements isolated from the human body and/or otherwise produced, such medicinal products resulting from technical processes aimed at obtaining elements similar in structure to those existing naturally in the human body and whereas, consequently, research aimed at obtaining and isolating such elements valuable to medicinal production should be encouraged by means of the patent system; (18) Whereas, since the patent system provides insufficient incentive for encouraging research into and production of biotechnological medicines which are needed to combat rare or ‘orphan’ diseases, the Community and the Member States have a duty to respond adequately to this problem; (19) Whereas account has been taken of Opinion No 8 of the Group of Advisers on the Ethical Implications of Biotechnology to the European Commission; (20) Whereas, therefore, it should be made clear that an invention based on an element isolated from the human body or otherwise produced by means of a technical process, which is susceptible of industrial application, is not excluded from patentability, even where the structure of that element is identical to that of a natural element, given that the rights conferred by the patent do not extend to the human body and its elements in their natural environment; (21) Whereas such an element isolated from the human body or otherwise produced is not excluded from patentability since it is, for example, the result of technical processes used to identify, purify and classify it and to reproduce it outside the human body, techniques which human beings alone are capable of putting into practice and which nature is incapable of accomplishing by itself; (22) Whereas the discussion on the patentability of sequences or partial sequences of genes is controversial; whereas, according to this Directive, the granting of a patent for inventions which concern such sequences or partial sequences should be subject to the same criteria of patentability as in all other areas of technology: novelty, inventive step and industrial application; whereas the industrial application of a sequence or partial sequence must be disclosed in the patent application as filed; (23) Whereas a mere DNA sequence without indication of a function does not contain any technical information and is therefore not a patentable invention; (24) Whereas, in order to comply with the industrial application criterion it is necessary in cases where a sequence or partial sequence of a gene is used to produce a protein or part of a protein, to specify which protein or part of a protein is produced or what function it performs; (25) Whereas, for the purposes of interpreting rights conferred by a patent, when sequences overlap only in parts which are not essential to the invention, each sequence will be considered as an independent sequence in patent law terms; (26) Whereas if an invention is based on biological material of human origin or if it uses such material, where a patent application is filed, the person from whose body the material is taken must have had an opportunity of expressing free and informed consent thereto, in accordance with national law; (27) Whereas if an invention is based on biological material of plant or animal origin or if it uses such material, the patent application should, where appropriate, include information on the geographical origin of such material, if known; whereas this is without prejudice to the processing of patent applications or the validity of rights arising from granted patents; (28) Whereas this Directive does not in any way affect the basis of current patent law, according to which a patent may be granted for any new application of a patented product; (29) Whereas this Directive is without prejudice to the exclusion of plant and animal varieties from patentability; whereas on the other hand inventions which concern plants or animals are patentable provided that the application of the invention is not technically confined to a single plant or animal variety; (30) Whereas the concept ‘plant variety’ is defined by the legislation protecting new varieties, pursuant to which a variety is defined by its whole genome and therefore possesses individuality and is clearly distinguishable from other varieties; (31) Whereas a plant grouping which is characterised by a particular gene (and not its whole genome) is not covered by the protection of new varieties and is therefore not excluded from patentability even if it comprises new varieties of plants; (32) Whereas, however, if an invention consists only in genetically modifying a particular plant variety, and if a new plant variety is bred, it will still be excluded from patentability even if the genetic modification is the result not of an essentially biological process but of a biotechnological process; (33) Whereas it is necessary to define for the purposes of this Directive when a process for the breeding of plants and animals is essentially biological; (34) Whereas this Directive shall be without prejudice to concepts of invention and discovery, as developed by national, European or international patent law; (35) Whereas this Directive shall be without prejudice to the provisions of national patent law whereby processes for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body are excluded from patentability; (36) Whereas the TRIPs Agreement provides for the possibility that members of the World Trade Organisation may exclude from patentability inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect ordre public or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to the environment, provided that such exclusion is not made merely because the exploitation is prohibited by their law; (37) Whereas the principle whereby inventions must be excluded from patentability where their commercial exploitation offends against ordre public or morality must also be stressed in this Directive; (38) Whereas the operative part of this Directive should also include an illustrative list of inventions excluded from patentability so as to provide national courts and patent offices with a general guide to interpreting the reference to ordre public and morality; whereas this list obviously cannot presume to be exhaustive; whereas processes, the use of which offend against human dignity, such as processes to produce chimeras from germ cells or totipotent cells of humans and animals, are obviously also excluded from patentability; (39) Whereas ordre public and morality correspond in particular to ethical or moral principles recognised in a Member State, respect for which is particularly important in the field of biotechnology in view of the potential scope of inventions in this field and their inherent relationship to living matter; whereas such ethical or moral principles supplement the standard legal examinations under patent law regardless of the technical field of the invention; (40) Whereas there is a consensus within the Community that interventions in the human germ line and the cloning of human beings offends against ordre public and morality; whereas it is therefore important to exclude unequivocally from patentability processes for modifying the germ line genetic identity of human beings and processes for cloning human beings; (41) Whereas a process for cloning human beings may be defined as any process, including techniques of embryo splitting, designed to create a human being with the same nuclear genetic information as another living or deceased human being; (42) Whereas, moreover, uses of human embryos for industrial or commercial purposes must also be excluded from patentability; whereas in any case such exclusion does not affect inventions for therapeutic or diagnostic purposes which are applied to the human embryo and are useful to it; (43) Whereas pursuant to Article F(2) of the Treaty on European Union, the Union is to respect fundamental rights, as guaranteed by the European Convention for the Protection of Human Rights and Fundamental Freedoms signed in Rome on 4 November 1950 and as they result from the constitutional traditions common to the Member States, as general principles of Community law; (44) Whereas the Commission's European Group on Ethics in Science and New Technologies evaluates all ethical aspects of biotechnology; whereas it should be pointed out in this connection that that Group may be consulted only where biotechnology is to be evaluated at the level of basic ethical principles, including where it is consulted on patent law; (45) Whereas processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit in terms of research, prevention, diagnosis or therapy to man or animal, and also animals resulting from such processes, must be excluded from patentability; (46) Whereas, in view of the fact that the function of a patent is to reward the inventor for his creative efforts by granting an exclusive but time-bound right, and thereby encourage inventive activities, the holder of the patent should be entitled to prohibit the use of patented self-reproducing material in situations analogous to those where it would be permitted to prohibit the use of patented, non-self-reproducing products, that is to say the production of the patented product itself; (47) Whereas it is necessary to provide for a first derogation from the rights of the holder of the patent when the propagating material incorporating the protected invention is sold to a farmer for farming purposes by the holder of the patent or with his consent; whereas that initial derogation must authorise the farmer to use the product of his harvest for further multiplication or propagation on his own farm; whereas the extent and the conditions of that derogation must be limited in accordance with the extent and conditions set out in Council Regulation (EC) No 2100/94 of 27 July 1994 on Community plant variety rights (6); (48) Whereas only the fee envisaged under Community law relating to plant variety rights as a condition for applying the derogation from Community plant variety rights can be required of the farmer; (49) Whereas, however, the holder of the patent may defend his rights against a farmer abusing the derogation or against a breeder who has developed a plant variety incorporating the protected invention if the latter fails to adhere to his commitments; (50) Whereas a second derogation from the rights of the holder of the patent must authorise the farmer to use protected livestock for agricultural purposes; (51) Whereas the extent and the conditions of that second derogation must be determined by national laws, regulations and practices, since there is no Community legislation on animal variety rights; (52) Whereas, in the field of exploitation of new plant characteristics resulting from genetic engineering, guaranteed access must, on payment of a fee, be granted in the form of a compulsory licence where, in relation to the genus or species concerned, the plant variety represents significant technical progress of considerable economic interest compared to the invention claimed in the patent; (53) Whereas, in the field of the use of new plant characteristics resulting from new plant varieties in genetic engineering, guaranteed access must, on payment of a fee, be granted in the form of a compulsory licence where the invention represents significant technical progress of considerable economic interest; (54) Whereas Article 34 of the TRIPs Agreement contains detailed provisions on the burden of proof which is binding on all Member States; whereas, therefore, a provision in this Directive is not necessary; (55) Whereas following Decision 93/626/EEC (7) the Community is party to the Convention on Biological Diversity of 5 June 1992; whereas, in this regard, Member States must give particular weight to Article 3 and Article 8(j), the second sentence of Article 16(2) and Article 16(5) of the Convention when bringing into force the laws, regulations and administrative provisions necessary to comply with this Directive; (56) Whereas the Third Conference of the Parties to the Biodiversity Convention, which took place in November 1996, noted in Decision III/17 that ‘further work is required to help develop a common appreciation of the relationship between intellectual property rights and the relevant provisions of the TRIPs Agreement and the Convention on Biological Diversity, in particular on issues relating to technology transfer and conservation and sustainable use of biological diversity and the fair and equitable sharing of benefits arising out of the use of genetic resources, including the protection of knowledge, innovations and practices of indigenous and local communities embodying traditional lifestyles relevant for the conservation and sustainable use of biological diversity’, HAVE ADOPTED THIS DIRECTIVE: CHAPTER I Patentability Article 1 1. Member States shall protect biotechnological inventions under national patent law. They shall, if necessary, adjust their national patent law to take account of the provisions of this Directive. 2. This Directive shall be without prejudice to the obligations of the Member States pursuant to international agreements, and in particular the TRIPs Agreement and the Convention on Biological Diversity. Article 2 1. For the purposes of this Directive, (a) ‘biological material’ means any material containing genetic information and capable of reproducing itself or being reproduced in a biological system; (b) ‘microbiological process’ means any process involving or performed upon or resulting in microbiological material. 2. A process for the production of plants or animals is essentially biological if it consists entirely of natural phenomena such as crossing or selection. 3. The concept of ‘plant variety’ is defined by Article 5 of Regulation (EC) No 2100/94. Article 3 1. For the purposes of this Directive, inventions which are new, which involve an inventive step and which are susceptible of industrial application shall be patentable even if they concern a product consisting of or containing biological material or a process by means of which biological material is produced, processed or used. 2. Biological material which is isolated from its natural environment or produced by means of a technical process may be the subject of an invention even if it previously occurred in nature. Article 4 1. The following shall not be patentable: (a) plant and animal varieties; (b) essentially biological processes for the production of plants or animals. 2. Inventions which concern plants or animals shall be patentable if the technical feasibility of the invention is not confined to a particular plant or animal variety. 3. Paragraph 1(b) shall be without prejudice to the patentability of inventions which concern a microbiological or other technical process or a product obtained by means of such a process. Article 5 1. The human body, at the various stages of its formation and development, and the simple discovery of one of its elements, including the sequence or partial sequence of a gene, cannot constitute patentable inventions. 2. An element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element. 3. The industrial application of a sequence or a partial sequence of a gene must be disclosed in the patent application. Article 6 1. Inventions shall be considered unpatentable where their commercial exploitation would be contrary to ordre public or morality; however, exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation. 2. On the basis of paragraph 1, the following, in particular, shall be considered unpatentable: (a) processes for cloning human beings; (b) processes for modifying the germ line genetic identity of human beings; (c) uses of human embryos for industrial or commercial purposes; (d) processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from such processes. Article 7 The Commission's European Group on Ethics in Science and New Technologies evaluates all ethical aspects of biotechnology. CHAPTER II Scope of protection Article 8 1. The protection conferred by a patent on a biological material possessing specific characteristics as a result of the invention shall extend to any biological material derived from that biological material through propagation or multiplication in an identical or divergent form and possessing those same characteristics. 2. The protection conferred by a patent on a process that enables a biological material to be produced possessing specific characteristics as a result of the invention shall extend to biological material directly obtained through that process and to any other biological material derived from the directly obtained biological material through propagation or multiplication in an identical or divergent form and possessing those same characteristics. Article 9 The protection conferred by a patent on a product containing or consisting of genetic information shall extend to all material, save as provided in Article 5(1), in which the product in incorporated and in which the genetic information is contained and performs its function. Article 10 The protection referred to in Articles 8 and 9 shall not extend to biological material obtained from the propagation or multiplication of biological material placed on the market in the territory of a Member State by the holder of the patent or with his consent, where the multiplication or propagation necessarily results from the application for which the biological material was marketed, provided that the material obtained is not subsequently used for other propagation or multiplication. Article 11 1. By way of derogation from Articles 8 and 9, the sale or other form of commercialisation of plant propagating material to a farmer by the holder of the patent or with his consent for agricultural use implies authorisation for the farmer to use the product of his harvest for propagation or multiplication by him on his own farm, the extent and conditions of this derogation corresponding to those under Article 14 of Regulation (EC) No 2100/94. 2. By way of derogation from Articles 8 and 9, the sale or any other form of commercialisation of breeding stock or other animal reproductive material to a farmer by the holder of the patent or with his consent implies authorisation for the farmer to use the protected livestock for an agricultural purpose. This includes making the animal or other animal reproductive material available for the purposes of pursuing his agricultural activity but not sale within the framework or for the purpose of a commercial reproduction activity. 3. The extent and the conditions of the derogation provided for in paragraph 2 shall be determined by national laws, regulations and practices. CHAPTER III Compulsory cross-licensing Article 12 1. Where a breeder cannot acquire or exploit a plant variety right without infringing a prior patent, he may apply for a compulsory licence for non-exclusive use of the invention protected by the patent inasmuch as the licence is necessary for the exploitation of the plant variety to be protected, subject to payment of an appropriate royalty. Member States shall provide that, where such a licence is granted, the holder of the patent will be entitled to a cross-licence on reasonable terms to use the protected variety. 2. Where the holder of a patent concerning a biotechnological invention cannot exploit it without infringing a prior plant variety right, he may apply for a compulsory licence for non-exclusive use of the plant variety protected by that right, subject to payment of an appropriate royalty. Member States shall provide that, where such a licence is granted, the holder of the variety right will be entitled to a cross-licence on reasonable terms to use the protected invention. 3. Applicants for the licences referred to in paragraphs 1 and 2 must demonstrate that: (a) they have applied unsuccessfully to the holder of the patent or of the plant variety right to obtain a contractual licence; (b) the plant variety or the invention constitutes significant technical progress of considerable economic interest compared with the invention claimed in the patent or the protected plant variety. 4. Each Member State shall designate the authority or authorities responsible for granting the licence. Where a licence for a plant variety can be granted only by the Community Plant Variety Office, Article 29 of Regulation (EC) No 2100/94 shall apply. CHAPTER IV Deposit, access and re-deposit of a biological material Article 13 1. Where an invention involves the use of or concerns biological material which is not available to the public and which cannot be described in a patent application in such a manner as to enable the invention to be reproduced by a person skilled in the art, the description shall be considered inadequate for the purposes of patent law unless: (a) the biological material has been deposited no later than the date on which the patent application was filed with a recognised depositary institution. At least the international depositary authorities which acquired this status by virtue of Article 7 of the Budapest Treaty of 28 April 1977 on the international recognition of the deposit of micro-organisms for the purposes of patent procedure, hereinafter referred to as the ‘Budapest Treaty’, shall be recognised; (b) the application as filed contains such relevant information as is available to the applicant on the characteristics of the biological material deposited; (c) the patent application states the name of the depository institution and the accession number. 2. Access to the deposited biological material shall be provided through the supply of a sample: (a) up to the first publication of the patent application, only to those persons who are authorised under national patent law; (b) between the first publication of the application and the granting of the patent, to anyone requesting it or, if the applicant so requests, only to an independent expert; (c) after the patent has been granted, and notwithstanding revocation or cancellation of the patent, to anyone requesting it. 3. The sample shall be supplied only if the person requesting it undertakes, for the term during which the patent is in force: (a) not to make it or any material derived from it available to third parties; and (b) not to use it or any material derived from it except for experimental purposes, unless the applicant for or proprietor of the patent, as applicable, expressly waives such an undertaking. 4. At the applicant's request, where an application is refused or withdrawn, access to the deposited material shall be limited to an independent expert for 20 years from the date on which the patent application was filed. In that case, paragraph 3 shall apply. 5. The applicant's requests referred to in point (b) of paragraph 2 and in paragraph 4 may only be made up to the date on which the technical preparations for publishing the patent application are deemed to have been completed. Article 14 1. If the biological material deposited in accordance with Article 13 ceases to be available from the recognised depositary institution, a new deposit of the material shall be permitted on the same terms as those laid down in the Budapest Treaty. 2. Any new deposit shall be accompanied by a statement signed by the depositor certifying that the newly deposited biological material is the same as that originally deposited. CHAPTER V Final provisions Article 15 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 30 July 2000. They shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. 2. Member States shall communicate to the Commission the text of the provisions of national law which they adopt in the field covered by this Directive. Article 16 The Commission shall send the European Parliament and the Council: (a) every five years as from the date specified in Article 15(1) a report on any problems encountered with regard to the relationship between this Directive and international agreements on the protection of human rights to which the Member States have acceded; (b) within two years of entry into force of this Directive, a report assessing the implications for basic genetic engineering research of failure to publish, or late publication of, papers on subjects which could be patentable; (c) annually as from the date specified in Article 15(1), a report on the development and implications of patent law in the field of biotechnology and genetic engineering. Article 17 This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities. Article 18 This Directive is addressed to the Member States. Done at Brussels, 6 July 1998. For the European Parliament The President J. M. GIL-ROBLES For the Council The President R. EDLINGER (1) OJ C 296, 8.10.1996, p. 4 and OJ C 311, 11.10.1997, p. 12. (2) OJ C 295, 7.10.1996, p. 11. (3) Opinion of the European Parliament of 16 July 1997 (OJ C 286, 22.9.1997, p. 87). Council Common Position of 26 February 1998 (OJ C 110, 8.4.1998, p. 17) and Decision of the European Parliament of 12 May 1998 (OJ C 167, 1.6.1998). Council Decision of 16 June 1998. (4) OJ C 68, 20.3.1995, p. 26. (5) OJ L 336, 23.12.1994, p. 213. (6) OJ L 227, 1.9.1994, p. 1. Regulation as amended by Regulation (EC) No 2506/95 (OJ L 258, 28.10.1995, p. 3). (7) OJ L 309, 31.12.1993, p. 1.

Summary: Biotechnological inventions: legal protection Biotechnological inventions: legal protection SUMMARY OF: Directive 98/44/EC — legal protection of biotechnological inventions SUMMARY WHAT DOES THIS DIRECTIVE DO? It harmonises national patent laws regarding biotechnological inventions. It specifies those inventions which are patentable on ethical grounds and those which are not. KEY POINTS Inventions which concern a product consisting of, or containing, biological material* or a process for the production of such biological material may be patented if they are new, involve an inventive step and can be applied industrially. The following are not patentable: plant and animal varieties essentially biological processes* for producing plants and animals the human body at the various stages of its formation and development. However, an element isolated from the human body or produced by a technical process may be a patentable invention. Inventions may not be patented where their commercialisation would be immoral or against public order. In particular, the following are not patentable: processes for cloning human beings processes that modify the human germ line genetic identity use of human embryos for industrial or commercial purposes processes that may cause suffering to animals when modifying their genetic identity. The protection granted by a patent also extends to any biological material derived from the original biological material. Where a plant breeder cannot use a plant variety without infringing a patent, they may apply for a compulsory licence for non-exclusive use of the invention, subject to payment of an appropriate royalty. The European Group on Ethics in Science and New Technologies evaluates all ethical aspects of biotechnology. In 2012, the European Commission set up an expert group to examine the technical development and implications of patent law in the field of biotechnology and genetic engineering. The group assists the Commission with its reporting obligations under Directive 98/44/EC. FROM WHEN DOES THE DIRECTIVE APPLY? It has applied since 30 July 1998. EU countries had to incorporate it into national law by 30 July 2000. Nowadays, the rules are implemented in the legislation of all EU countries. BACKGROUND Protection of biotechnological inventions KEY TERMS * Biological material: any material containing genetic information and capable of reproducing itself or being reproduced in a biological system. * Biological process: a process for the production of plants and animals is essentially biological if it consists entirely of natural phenomena such as crossing or selection. ACT Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions (OJ L 213, 30.7.1998, pp. 13–21) last update 21.03.2016


EUR-Lex - 32002L0032 - EN Avis juridique important | 32002L0032 Directive 2002/32/EC of the European Parliament and of the Council of 7 May 2002 on undesirable substances in animal feed - Council statement Official Journal L 140 , 30/05/2002 P. 0010 - 0022 Directive 2002/32/EC of the European Parliament and of the Councilof 7 May 2002on undesirable substances in animal feedTHE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 152(4)(b) thereof,Having regard to the proposal from the Commission(1),Having regard to the opinion of the Economic and Social Committee(2),After consulting the Committee of the Regions,Acting in accordance with the procedure laid down in Article 251 of the Treaty(3), in the light of the joint text approved by the Conciliation Committee on 26 March 2002,Whereas:(1) Many amendments need to be made to Council Directive 1999/29/EC of 22 April 1999 on the undesirable substances and products in animal nutrition(4). In the interests of clarity and efficiency the said Directive should be recast.(2) Livestock production occupies a very important place in farming in the Community and satisfactory results in terms of public and animal health, animal welfare, the environment and the livestock producers' finances depend to a large extent on the use of appropriate good quality feedingstuffs.(3) Rules on feedingstuffs are needed to ensure agricultural productivity and sustainability and to make it possible to ensure public and animal health, animal welfare and the environment. In addition, there is a need for comprehensive regulation on hygiene in order to guarantee good quality feedingstuffs on individual farms even when they are not commercially produced.(4) The same rules concerning the quality and safety of products intended for animal feed have to apply to the quality and safety of water consumed by the animals. Although the definition of feedingstuffs does not preclude water being considered as feedingstuff, it is not included in the non-exhaustive list of main feed materials, laid down by Council Directive 96/25/EC of 29 April 1996 on the circulation and use of feed materials(5). The issue of water to be considered as feedingstuffs needs to be examined in the framework of that Directive.(5) It has been established that additives can contain undesirable substances. The scope of the Directive should therefore be extended to cover additives.(6) Products intended for animal feed may contain undesirable substances which can endanger animal health or, because of their presence in livestock products, human health or the environment.(7) It is impossible to eliminate fully the presence of undesirable substances but it is important that their content in products intended for animal feed should be reduced, with due regard to the substances' acute toxicity, bio-accumulability and degradability, in order to prevent undesirable and harmful effects. It is at present inappropriate to fix this content below the levels detectable by methods of analysis to be defined for the Community.(8) The methods for determining residues of undesirable substances are becoming increasingly sophisticated, so that even quantities of residues which are negligible for animal and human health can be detected.(9) Undesirable substances may be present in products intended for animal feed only in accordance with the conditions laid down in this Directive and may not be used in any other way for the purposes of animal feed. This Directive should therefore apply without affecting other Community provisions on feedingstuffs, and particularly the rules applicable to compound feedingstuffs.(10) This Directive must apply to products intended for animal feed as soon as they enter the Community. It must therefore be stipulated that the maximum levels of undesirable substances that are set apply in general from the date on which the products intended for animal feed are put into circulation or used, at all stages, and in particular as soon as they are imported.(11) Products intended for animal feed must be sound, genuine and of merchantable quality and therefore when correctly used must not represent any danger to human health, animal health or to the environment or adversely affect livestock production. Using or putting into circulation products intended for animal feed which contain levels of undesirable substances that exceed the maximum levels laid down in Annex I must therefore be prohibited.(12) The presence of certain undesirable substances in complementary feedingstuffs must be limited by fixing appropriate maximum levels.(13) While in certain cases a maximum level is fixed, taking account of background levels, continued effort is still needed to restrict the presence of some specific undesirable substances to the lowest possible levels in products intended for animal feed so as to reduce their presence in the feed and food chain. It should therefore be permitted, under this Directive, to lay down action thresholds well below the maximum levels fixed. Where such action thresholds are exceeded, investigations must be carried out to identify the sources of the undesirable substances and steps taken to reduce or eliminate such sources.(14) Where animal or human health or the environment is endangered, Member States should be allowed temporarily to reduce the fixed maximum permissible levels, to fix maximum levels for other substances or to prohibit the presence of such substances in products intended for animal feed. In order to ensure a uniform application, any amendments to Annex I to this Directive should be decided on by emergency Community procedure, on the basis of supporting documents and the precautionary principle.(15) Products intended for animal feed that satisfy the requirements of this Directive may not be subject to restrictions on entry into circulation, as regards the level of undesirable substances they contain, other than those provided for in this Directive and in Council Directive 95/53/EC of 25 October 1995 fixing the principles governing the organisation of official inspections in the field of animal nutrition(6).(16) Member States must make appropriate monitoring arrangements pursuant to Directive 95/53/EC to ensure that the requirements regarding undesirable substances are met when products intended for animal feed are used or circulated.(17) An appropriate Community procedure is needed for adapting the technical provisions in the Annexes to this Directive in the light of developments in scientific and technical knowledge.(18) In order to facilitate implementation of the proposed measures, there should be a procedure for close cooperation between the Member States and the Commission within the Standing Committee for Feedingstuffs set up by Decision 70/372/EEC(7).(19) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(8),HAVE ADOPTED THIS DIRECTIVE:Article 11. This Directive deals with undesirable substances in products intended for animal feed.2. This Directive shall apply without prejudice to the provisions in:(a) Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs(9);(b) Council Directive 96/25/EC and Council Directive 79/373/EEC of 2 April 1979 on the marketing of compound feedingstuffs(10);(c) Council Directive 76/895/EEC of 23 November 1976 relating to the fixing of maximum levels for pesticide residues in and on fruit and vegetables(11), Council Directive 86/362/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on cereals(12), Council Directive 86/363/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on foodstuffs of animal origin(13) and Council Directive 90/642/EEC of 27 November 1990 on the fixing of maximum levels for pesticide residues in and on certain products of plant origin, including fruit and vegetables(14), where these residues are not listed in Annex I to this Directive;(d) Community legislation concerning veterinary matters relating to public health and animal health;(e) Council Directive 82/471/EEC of 30 June 1982 concerning certain products used in animal nutrition(15);(f) Council Directive 93/74/EEC of 13 September 1993 on feedingstuffs intended for particular nutritional purposes(16).Article 2For the purposes of this Directive:(a) "feedingstuffs" shall mean products of vegetable or animal origin, in their natural state, fresh or preserved, and products derived from the industrial processing thereof, and organic or inorganic substances, used singly or in mixtures, whether or not containing additives, for oral animal feeding;(b) "feed materials" shall mean various products of vegetable or animal origin, in their natural state, fresh or preserved, and products derived from the industrial processing thereof, and organic or inorganic substances, whether or not containing additives, which are intended for use in oral animal feeding either directly as such or, after processing, in the preparation of compound feedingstuffs or as substrates for premixtures;(c) "additives" shall mean additives as defined in Article 2(a) of Council Directive 70/524/EEC;(d) "premixtures" shall mean mixtures of additives or mixtures of one or more additives with substances used as carriers, intended for the manufacture of feedingstuffs;(e) "compound feedingstuffs" shall mean mixtures of feed materials, whether or not containing additives, which are intended for oral animal feeding as complete or complementary feedingstuffs;(f) "complementary feedingstuffs" shall mean mixtures of feedingstuffs which have a high content of certain substances and which, by reason of their composition, are sufficient for a daily ration only if used in combination with other feedingstuffs;(g) "complete feedingstuffs" shall mean mixtures of feedingstuffs which, by reason of their composition, are sufficient for a daily ration;(h) "products intended for animal feed" shall mean feed materials, premixtures, additives, feedingstuffs and all other products intended for use or used in animal feed;(i) "daily ration" shall mean the average total quantity of feedingstuffs, calculated on a moisture content of 12 %, required daily by an animal of a given species, age class and yield, to satisfy all its needs;(j) "animals" shall mean animals belonging to species normally fed and kept or consumed by man as well as animals living freely in the wild in cases where they are fed with feedingstuffs;(k) "putting into circulation" or "circulation" shall mean the holding of products intended for animal feed for the purposes of sale, including offering for sale, or any other form of transfer, whether free or not, to third parties, and the sale or other forms of transfer themselves;(l) "undesirable substance" shall mean any substance or product, with the exception of pathogenic agents, which is present in and/or on the product intended for animal feed and which presents a potential danger to animal or human health or to the environment or could adversely affect livestock production.Article 31. Products intended for animal feed may enter for use in the Community from third countries, be put into circulation and/or used in the Community only if they are sound, genuine and of merchantable quality and therefore when correctly used do not represent any danger to human health, animal health or to the environment or could adversely affect livestock production.2. In particular, products intended for animal feed shall be deemed not to be in conformity with paragraph 1 if the level of undesirable substances they contain does not comply with the maximum levels laid down in Annex I.Article 41. Member States shall prescribe that the undesirable substances listed in Annex I may be tolerated in products intended for animal feed only subject to the conditions laid down therein.2. In order to reduce or eliminate sources of undesirable substances of products intended for animal feed, Member States, in cooperation with economic operators, shall carry out investigations to identify the sources of undesirable substances, in cases where the maximum levels are exceeded and in cases where increased levels of such substances are detected, taking into account background levels. For a uniform approach in cases of increased levels it may be necessary to set action thresholds to trigger such investigations. These may be laid down in Annex II.Member States shall transmit to the Commission and the other Member States all relevant information and findings of the source and the measures taken to reduce the level or elimination of the undesirable substances. This information shall be transmitted in the frame of the annual report to be transmitted to the Commission according to the provisions of Article 22 of Directive 95/53/EC except in those cases where the information is of immediate relevance for the other Member States. In this latter case, the information shall be transmitted immediately.Article 5Member States shall prescribe that products intended for animal feed containing levels of an undesirable substance that exceed the maximum level fixed in Annex I may not be mixed for dilution purposes with the same, or other, products intended for animal feed.Article 6In so far as there are no special provisions for complementary feedingstuffs, Member States shall prescribe that complementary feedingstuffs may not, taking into account the proportion prescribed for their use in a daily ration, contain levels of the undesirable substances listed in Annex I that exceed those fixed for complete feedingstuffs.Article 71. Where a Member State has grounds, based on new information or a reassessment of existing information made since the provisions in question were adopted, demonstrating that a maximum level fixed in Annex I or an undesirable substance not listed therein present a danger to animal or human health or to the environment, that Member State may provisionally reduce the existing maximum level, fix a maximum level or prohibit the presence of that undesirable substance in products intended for animal feed. It shall immediately inform the other Member States and the Commission thereof, stating the grounds for its decision.2. An immediate decision shall be taken, in accordance with the procedure laid down in Article 12, as to whether Annexes I and II should be amended.So long as neither the Council nor the Commission has taken a decision, the Member State may maintain the measures it has implemented.The Member State must ensure that the decision taken is made public.Article 81. In accordance with the procedure laid down in Article 11, the Commission, in the light of developments in scientific and technical knowledge, shall adapt Annexes I and II.2. Furthermore, in accordance with the procedure laid down in Article 11, the Commission:- shall periodically adopt consolidated versions of Annexes I and II incorporating any adaptations made pursuant to paragraph 1,- may define acceptability criteria for detoxification processes as a complement to the criteria provided for products intended for animal feed which have undergone such processes.3. Member States shall ensure that measures are taken to guarantee the correct application of any acceptable processes pursuant to paragraph 2 and the conformity of the detoxified products intended for animal feed with the provisions of Annex I.Article 9Member States shall ensure that products intended for animal feed which comply with this Directive are not subject to any other restrictions on circulation as regards the presence of undesirable substances other than those provided for in this Directive and Directive 95/53/EC.Article 10Provisions that may have an effect upon public or animal health or on the environment shall be adopted after consultation with the appropriate Scientific Committee(s).Article 111. The Commission shall be assisted by the Standing Committee for Feedingstuffs, set up by Article 1 of Decision 70/372/EEC.2. Where reference is made to this Article, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.3. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.Article 121. The Commission shall be assisted by the Standing Committee for Feedingstuffs, set up by Article 1 of Decision 70/372/EEC.2. Where reference is made to this Article, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.3. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at fifteen days.Article 131. The Member States shall apply at least the provisions of this Directive to products intended for animal feed produced in the Community to be exported to third countries.2. Paragraph 1 shall not affect the right of Member States to authorise re-exportation under the conditions laid down in Article 12 of Regulation (EC) No 178/2002(17). The provisions of Article 20 thereof shall apply mutatis mutandis.Article 141. Directive 1999/29/EC is hereby repealed as from 1 August 2003, without prejudice to the obligations of the Member States to comply with the deadlines set out in Part B of Annex III thereto for the transposition of the Directives listed in Part A of that Annex.2. References to Directive 1999/29/EC shall be construed as references to this Directive and should be read in accordance with the correlation table in Annex III.Article 15Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive before 1 May 2003. They shall forthwith inform the Commission thereof.The measures adopted shall apply as from 1 August 2003.When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The procedure for making such reference shall be adopted by Member States.Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field covered by this Directive.Article 16This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.Article 17The Directive is addressed to the Member States.Done at Brussels, 7 May 2002.For the European ParliamentThe PresidentP. CoxFor the CouncilThe PresidentR. De Rato Y Figaredo(1) OJ C 89 E, 28.3.2000, p. 70 and OJ C 96 E, 27.3.2001, p. 346.(2) OJ C 140, 18.5.2000, p. 9.(3) Opinion of the European Parliament of 4 October 2000 (OJ C 178, 22.6.2001, p. 160), Council Common Position of 17 September 2001 (OJ C 4, 7.1.2002, p. 1) and Decision of the European Parliament of 12 December 2001 (not yet published in the Official Journal). Decision of the European Parliament of 10 April 2002 and Decision of the Council of 22 April 2002.(4) OJ L 115, 4.5.1999, p. 32.(5) OJ L 125, 23.5.1996, p. 35. Directive as last amended by European Parliament and Council Directive 2000/16/EC (OJ L 105, 3.5.2000, p. 36).(6) OJ L 265, 8.11.1995, p. 17. Directive as last amended by Directive 2001/46/EC of the European Parliament and of the Council (OJ L 234, 1.9.2001, p. 55).(7) OJ L 170, 3.8.1970, p. 1.(8) OJ L 184, 17.7.1999, p. 23.(9) OJ L 270, 14.12.1970, p. 1. Directive as last amended by Commission Regulation (EC) No 2205/2001 (OJ L 297, 15.11.2001, p. 3).(10) OJ L 86, 6.4.1979, p. 30. Directive as last amended by the European Parliament and Council Directive 2002/2/EC (OJ L 63, 6.3.2002, p. 23).(11) OJ L 340, 9.12.1976, p. 26. Directive as last amended by Commission Directive 2000/57/EC (OJ L 244, 29.9.2000, p. 76).(12) OJ L 221, 7.8.1986, p. 37. Directive as last amended by Commission Directive 2002/23/EC (OJ L 64, 7.3.2002, p. 13).(13) OJ L 221, 7.8.1986, p. 43. Directive as last amended by Directive 2002/23/EC.(14) OJ L 350, 14.12.1990, p. 71. Directive as last amended by Directive 2002/23/EC.(15) OJ L 213, 21.7.1982, p. 8. Directive as last amended by Directive 1999/20/EC (OJ L 80, 25.3.1999, p. 20).(16) OJ L 237, 22.9.1993, p. 23. Directive as last amended by Directive 1999/29/EC (OJ L 115, 4.5.1999, p. 32).(17) Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1).ANNEX I>TABLE>ANNEX II>PIC FILE= "L_2002140EN.001902.TIF">ANNEX IIICORRELATION TABLE>TABLE>Council statementThe Member States confirm that they shall do their utmost to ensure that the relevant measures needed to implement the Directive are adopted expeditiously within the time period laid down in Articles 14 and 15.

Summary: Ensuring safe animal feed Ensuring safe animal feed SUMMARY OF: Directive 2002/32/EC on undesirable substances in animal feed SUMMARY WHAT DOES THIS DIRECTIVE DO? It sets maximum levels for undesirable substances and products* (contaminants) in animal feed (including imports) available on the EU market. It limits the risks of contamination of animal feed by substances and products that are toxic or adversely affect production. KEY POINTS Scope The directive applies to all products intended for animal feed, including raw materials for feed, additives and complementary feedingstuffs. It lays down a list of undesirable substances and specifies the limit values for which the presence of these substances in animal feeds is forbidden (Annex I). The list includes substances such as certain heavy metals (like lead and cadmium), dioxin and some pesticides. It is regularly updated in the light of scientific and technical knowledge. Investigations When these maximum levels are exceeded, EU countries – in cooperation with the businesses concerned – must investigate to identify the sources of the substances. They must inform the European Commission of their findings and of any measures taken to eliminate or reduce the level of the substances. Mixtures To prevent fraud, the directive bans the mixing (for dilution purposes) of products which exceed the maximum levels. Provisional measures Where an EU country can demonstrate that a maximum level fixed for a substance may present a risk to animal or human health or to the environment, it may provisionally introduce more stringent limits until either the Council or the Commission takes a decision. The country in question must ensure that its decision is made public. WHEN DOES THE DIRECTIVE APPLY? It entered into force on 30 May 2002. EU countries had to incorporate it in national law by 1 May 2003. BACKGROUND Animal nutrition — undesirable substances KEY TERM * Undesirable substance: any substance or product, with the exception of pathogenic agents, present in and/or on the product intended for animal feed, which presents a potential danger to animal or human health, to the environment or could adversely affect livestock production. ACT Directive 2002/32/EC of the European Parliament and of the Council of 7 May 2002 on undesirable substances in animal feed — Council statement (OJ L 140, 30.5.2002, pp. 10-22) Successive amendments to Directive 2002/32/EC and its Annexes have been incorporated into the original text. This consolidated version is of documentary value only. RELATED ACTS Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (OJ L 165, 30.4.2004, pp. 1-141). Text republished in corrigendum (OJ L 191, 28.5.2004, pp. 1–52) See consolidated version. last update 04.01.2016