EUR-Lex - 31996L0022 - EN Avis juridique important | 31996L0022 Council Directive 96/22/EC of 29 April 1996 concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of ß-agonists, and repealing Directives 81/602/EEC, 88/146/EEC and 88/299/EEC Official Journal L 125 , 23/05/1996 P. 0003 - 0009 COUNCIL DIRECTIVE 96/22/EC of 29 April 1996 concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of beta-agonists, and repealing Directives 81/602/EEC, 88/146/EEC and 88/299/EECTHE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 43 thereof,Having regard to the proposal from the Commission (1),Having regard to the opinion of the European Parliament (2),Having regard to the opinion of the Economic and Social Committee (3),(1) Whereas Directive 81/602/EEC (4) prohibits certain substances having a hormonal action and any substances having a thyrostatic action and whereas Directive 88/146/EEC (5) prohibits the use in stockfarming of certain substances having a hormonal action, whilst conceding derogations;(2) Whereas Council Directive 88/299/EEC (6) lays down the conditions for applying the derogations provided for in Article 7 of Directive 88/146/EEC from the prohibition on trade in certain categories of animals and their meat;(3) Whereas, on account of the residues they leave in meat and other foodstuffs of animal origin, certain substances having a thyrostatic, oestrogenic, androgenic or gestagenic action may be dangerous for consumers and may also affect the quality of foodstuffs of animal origin;(4) Whereas new substances having an anabolizing action such as beta-agonists are used illegally in livestock-rearing with a view to stimulating the growth and yield of animals;(5) Whereas the results of an enquiry conducted by the Commission in the Member States from 1990 to 1992 show that beta-agonists are widely available in the livestock-rearing sector, leading to their illegal use;(6) Whereas the improper use of beta-agonists can be a serious risk to human health; whereas, in the interests of the consumer, the holding, administering to animals of any species and the placing on the market for that purpose of beta-agonists should be prohibited; whereas, moreover, the holding, administering to animals of any species and the placing on the market of stilbenes and thyrostatic substances should be prohibited and the use of other substances regulated;(7) Whereas, however, the administering of medicinal products based on beta-agonists may be authorized for well-defined therapeutic purposes, in the case of certain categories of bovine animals, equidae and pets;(8) Whereas, moreover, it is necessary to ensure that all consumers are able to acquire meat and foodstuffs derived therefrom under the same conditions of supply and that those products correspond as closely as possible to their concerns and expectations; whereas, given consumer sensitivity, this can only bring about an increase in the consumption of the products in question;(9) Whereas the prohibition on the use of hormonal substances for fattening purposes should continue to apply; whereas the use of certain substances for therapeutic or zootechnical purposes may be authorized but must be strictly controlled in order to prevent any misuse;(10) Whereas withdrawal periods are not harmonized at Community level and there are considerable differences between Member States, particularly as regards authorized veterinary medicinal products containing hormonal substances or beta-agonists; whereas, in the interests of harmonization, maximum withdrawal periods should therefore be set for such medicinal products;(11) Whereas, furthermore, live animals so treated for therapeutic or zootechnical purposes and the meat from such animals should not as a general rule be traded, since this could impair the effectiveness of the control arrangements of the scheme as a whole; whereas, however, derogations from the prohibition may, subject to certain conditions, be provided for in respect of intra-Community trade and imports from third countries of animals intended for breeding and breeding animals at the end of their reproductive life;(12) Whereas such derogations may be authorized where adequate guarantees are provided so as to prevent distortion of trade; whereas such guarantees must cover the products which may be used, the conditions governing their use and the checks to ensure that the conditions are complied with, particularly with regard to the necessary withdrawal period;(13) Whereas provision should be made for the effective verification of application of the provisions deriving from this Directive;(14) Whereas Directives 81/602/EEC, 88/146/EEC and 88/299/EEC should be repealed;(15) Whereas, if the illegal use of growth and productivity promoters in stockfarming is to be combated effectively in all Member States, action will have to be organized at Community level;(16) Whereas, on 18 January 1996, the European Parliament asked the Commission and the Council to continue opposing the importation into the Community of meat treated with hormones, requested the maintenance of the total ban on the use of growth promoters in stockfarming and, to that end, asked the Council to adopt without delay the Commission proposal on which the European Parliament had delivered its opinion on 19 April 1994,HAS ADOPTED THIS DIRECTIVE:Article 11. For the purposes of this Directive, the definitions of meat and meat products given in Directives 64/433/EEC (7), 71/118/EEC (8), 77/99/EEC (9), and 91/495/EEC (10), the definitions of aquaculture products given in Directive 91/493/EEC (11) and the definitions of veterinary medicinal products given in Directives 81/851/EEC (12) and 81/852/EEC (13) shall apply.2. In addition, the following definitions shall apply:(a) 'farm animals` shall mean domestic animals of the bovine, porcine, ovine and caprine species, domestic solipeds, poultry and rabbits, as well as wild animals of those species and wild ruminants which have been raised on a holding;(b) 'therapeutic treatment` shall mean the administering - under Article 4 of this Directive - to an individual farm animal of an authorized substance to treat, after examination by a veterinarian, a fertility problem - including the termination of unwanted gestation - and, in the case of beta-agonists, to induce tocolysis in cows when calving and to treat respiratory problems and to induce tocolysis in equidae raised for purposes other than meat production;(c) 'zootechnical treatment` shall mean the administering:(i) to an individual farm animal of any substance authorized under Article 5 of this Directive for synchronizing oestrus and preparing donors and recipients for the implantation of embryos, after examination of the animal by a veterinarian or, in accordance with the second paragraph of Article 5, under his responsibility;(ii) in the case of aquaculture animals, to a group of breeding animals for sex inversion, on a veterinarian's prescription and under his responsibility;(d) 'illegal treatment` shall mean the use of unauthorized substances or products or the use of substances or products authorized under Community legislation for purposes or under conditions other than those laid down in Community legislation.Article 2Member States shall prohibit:(a) the placing on the market of stilbenes, stilbene derivatives, their salts and esters and thyrostatic substances for administering to animals of all species;(b) the placing on the market of beta-agonists for administering to animals the flesh and products of which are intended for human consumption for purposes other than those provided for in point 2 of Article 4.Article 3Member States shall prohibit:(a) the administering to a farm or aquaculture animal, by any means whatsoever, of substances having a thyrostatic, oestrogenic, androgenic or gestagenic action and of beta-agonists;(b) the holding, except under official control, of animals referred to in (a) on a farm, the placing on the market or slaughter for human consumption of farm animals or of aquaculture animals which contain the substances referred to in (a) or in which the presence of such substances has been established, unless proof can be given that the animals in question have been treated in accordance with Articles 4 or 5;(c) the placing on the market for human consumption of aquaculture animals to which substances referred to in (a) have been administered and of processed products derived from such animals;(d) the placing on the market of meat of the animals referred to in (b);(e) the processing of the meat referred to in (d).Article 4Notwithstanding Articles 2 and 3, Member States may authorize:1. the administering to farm animals, for therapeutic purposes, of oestradiol 17 â, testosterone and progesterone and derivatives which readily yield the parent compound on hydrolysis after absorption at the site of application. Veterinary medicinal products used for therapeutic treatment must comply with the requirements for placing on the market laid down in Directive 81/851/EEC and be administered only by a veterinarian, by injection or for the treatment of ovarian dysfunction in the form of vaginal spirals, but not by implant, to farm animals which have been clearly identified. Treatment of identified animals must be registered by the veterinarian responsible. The latter must record at least the following details in a register, which may be the one provided for in Directive 81/851/EEC:- type of treatment,- the type of products authorized,- the date of treatment,- the identity of the animals treated.The register must be made available to the competent authority at its request;2. the administering for therapeutic purposes of authorized veterinary medicinal products containing:(i) allyl trenbolone, administered orally, or beta-agonists to equidae and pets, provided they are used in accordance with the manufacturer's instructions;(ii) beta-agonists, in the form of an injection to induce tocolysis in cows when calving.Such substances must be administered by a veterinarian or, in the case of the veterinary medicinal products referred to in (i), under his direct responsibility; treatment must be registered by the veterinarian responsible, who shall record at least the details referred to in point 1.Farmers shall be prohibited from holding veterinary medicinal products containing beta-agonists which may be used for induction purposes in the treatment of tocolysis.However, without prejudice to the first subparagraph of point 2 (ii), therapeutic treatment of production animals, including breeding animals at the end of their reproductive life, shall be prohibited.Article 5Notwithstanding Article 3 (a) and without prejudice to Article 2, Member States may authorize the administering to farm animals, for the purpose of zootechnical treatment, of veterinary medicinal products having an oestrogenic, androgenic or gestagenic action which are authorized in accordance with Directives 81/851/EEC and 81/852/EEC. Such veterinary medicinal products must be administered by a veterinarian to clearly identified animals; the treatment must be recorded by the veterinarian responsible in accordance with point 1 of Article 4.However, Member States may allow the synchronization of oestrus and the preparation of donors and recipients for the implantation of embryos to be effected not by the veterinarian direct, but under his responsibility.With regard to aquaculture animals young fish may be treated for the first three months for the purpose of sex inversion with veterinary medicinal products that have an androgenous action and are authorized in accordance with Directives 81/851/EEC and 81/852/EEC.In the cases provided for in this Article, the veterinarian shall make out a non-renewable prescription, specifying the treatment in question and the quantity of the product required and shall record the products prescribed.However, zootechnical treatment of production animals, including during the fattening period for breeding animals at the end of their reproductive life, shall be prohibited.Article 61. Hormonal products and beta-agonists the administration of which to farm animals is authorized in accordance with Articles 4 and 5 must meet the requirements of Directives 81/851/EEC and 81/852/EEC.2. The following may not, however, be authorized in accordance with paragraph 1:(a) the following hormonal products:(i) products acting as a deposit;(ii) products with a withdrawal period of more than 15 days after the end of treatment;(iii) products:- which were authorized under rules that preceded the amendment made by Regulation (EEC) No 2309/93 (14),- whose conditions of use are not known,- for which no reagents or equipment exist for use in the analytical techniques for detecting the presence of residues in excess of the permitted limits,(b) veterinary medicinal products containing beta-agonists which have a withdrawal period of more than 28 days after the end of treatment.Article 71. For the purpose of trade, Member States may authorize the placing on the market of animals for breeding and breeding animals at the end of their reproductive life which, during the latter period, have undergone a treatment referred to in Articles 4 and 5 and may authorize the affixing of the Community stamp to meat from such animals where the conditions laid down in Articles 4 and 5 and the minimum withdrawal periods laid down in Article 6 (2), under (a) (ii) or (b) respectively or the withdrawal periods provided for in the authorization to place on the market are complied with.However, trade in high-value horses, and in particular racehorses, competition horses, circus horses or horses intended for stud purposes or for exhibitions, including registered equidae to which veterinary medicinal products containing allyl trenbolone or beta-agonists have been administered for the purposes referred to in Article 4, may take place before the end of the withdrawal period, provided that the conditions governing administration are fulfilled and that the type and date of treatment are entered on the certificate or passport accompanying these animals.2. Meat or products from animals to which substances having an oestrogenic, androgenic or gestagenic action or beta-agonists have been administered in accordance with the dispensatory provisions of this Directive may not be placed on the market for human consumption unless the animals in question have been treated with veterinary medicinal products complying with the requirements of Article 6 and in so far as the withdrawal period laid down was observed before the animals were slaughtered.Article 8Member States shall ensure that:1. at the time of the import, manufacture, storage, distribution, sale and use of the substances referred to in Articles 2 and 3 (a), their possession is restricted to the persons authorized by national legislation in accordance with Article 1 of Directive 90/676EEC (15);2. in addition to the checks provided for in the Directives governing the placing on the market of the various products in question, the official checks provided for in Article 11 of Directive 96/23/EC (16) are carried out by the competent national authorities without prior notice, with a view to ascertaining:(a) the possession or presence of substances or products prohibited under Article 2, intended to be administered to animals for the purpose of fattening;(b) the illegal treatment of animals;(c) failure to observe the withdrawal periods provided for in Article 6;(d) failure to observe the restrictions on the use of certain substances or products laid down in Articles 4 and 5;3. the tests for the presence of:(a) the substances referred to in point 1 in animals, in the drinking water of animals and in all places where animals are bred or kept;(b) residues of the aforementioned substances in live animals, their excrement and body fluids and in animal tissues and productsare carried out in accordance with Annexes III and IV to Directive 96/23/EC;4. where the checks provided for in points 2 and 3 reveal:(a) the presence of substances or products the use or possession of which is prohibited, or the presence of residues of substances the administering of which comes under the heading of illegal treatment, such substances or products are confiscated, while any animals treated or the meat therefrom is placed under official supervision until the requisite penalties have been applied;(b) failure to comply with the requirements of points 2 (b) and (c), the competent authority takes appropriate measures consistent with the gravity of the infringement.Article 9Without prejudice to Directive 81/851/EEC, undertakings buying or producing substances having a thyrostatic, oestrogenic, androgenic or gestagenic action and beta-agonists, undertakings authorized in any capacity to market such substances and undertakings buying or producing pharmaceutical and veterinary medicinal products from such substances shall be required to keep registers detailing, in chronological order, quantities produced or acquired and those sold or used for the production of pharmaceutical and veterinary medicinal products and the names of the persons to whom such quantities were sold or from whom they were purchased.The above information must be made available to the competent authority at its request and, in the case of computerized records, in the form of a printout.Article 10Where the results of checks carried out in a Member State show failure to comply with the requirements of this Directive in the country of origin of the animals or products, the competent authority of that Member State shall have recourse to Council Directive 89/608/EEC of 21 November 1989 on mutual assistance between the administrative authorities of the Member States and cooperation between the latter and the Commission to ensure the correct application of legislation on veterinary and zootechnical matters (17).Article 111. Third countries whose legislation authorizes the placing on the market and administration of stilbenes, stilbene derivatives, their salts and esters, or of thyrostatic substances for administering to animals of all species may not appear on any of the lists of countries provided for under Community legislation from which Member States are authorized to import farm or aquaculture animals or meat or products obtained from such animals.2. Member States shall also prohibit the importation from third countries on any of the lists referred to in paragraph 1 of:(a) farm or aquaculture animals(i) to which products or substances referred to in point (a) of Article 2 have been administered by any means whatsoever;(ii) to which substances or products referred to in point (a) of Article 3 have been administered, unless those substances or products were administered in compliance with the provisions and requirements laid down in Articles 4, 5 and 7 and the withdrawal periods allowed in international recommendations have been observed;(b) meat or products obtained from animals the importation of which is prohibited under point (a).3. However, animals intended for breeding, breeding animals at the end of their reproductive life, or meat therefrom, from third countries may be imported subject to their affording guarantees at least equivalent to those laid down in this Directive, which have been established in accordance with the procedure laid down in Article 33 of Directive 96/23/EC for the purpose of giving effect to Chapter V of that Directive.4. Checks on imports from third countries shall be carried out in accordance with Article 4 (2) (c) of Council Directive 91/496/EEC of 15 July 1991 laying down the principles governing the organization of veterinary checks on animals entering the Community from third countries (18) and Article 8 (2) of Council Directive 90/675/EEC of 10 December 1990 laying down the principles governing the organization of veterinary checks on products entering the Community from third countries (19).Article 12The Council, acting by a qualified majority on a proposal from the Commission, may adopt transitional measures necessary for the introduction of the arrangements provided for in this Directive.Article 131. Directives 81/602/EEC, 88/146/EEC and 88/299EEC are hereby repealed as from 1 July 1997.2. References made to the repealed Directives shall be construed as being made to this Directive and should be read in accordance with the correlation table in the Annex.Article 141. Member States shall bring into force the laws, regulations and administrative provisions, including any penalties, necessary to comply with this Directive on 1 July 1997, and, for beta-agonists, by 1 July 1997 at the latest. 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 main provisions of national law which they adopt in the field governed by this Directive.3. Pending application of the provisions of this Directive as regards beta-agonists, the relevant national rules shall continue to apply in compliance with the general provisions of the Treaty.Article 15This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.Article 16This Directive is addressed to the Member States.Done at Luxembourg, 29 April 1996.For the CouncilThe PresidentW. LUCHETTI(1) OJ No C 302, 9. 11. 1993, p. 8 and OJ No C 222, 10. 8. 1994, p. 16.(2) OJ No C 128, 9. 5. 1994, p. 107.(3) OJ No C 52, 19. 2. 1994, p. 30.(4) OJ No L 222, 7. 8. 1981, p. 32. Directive as amended by Directive 85/358/EEC (OJ No L 191, 23. 7. 1985, p. 46).(5) OJ No L 70, 16. 3. 1988, p. 16. Directive as amended by the 1994 Act of Accession.(6) OJ No L 128, 21. 5. 1988, p. 36.(7) OJ No 121, 29. 7. 1964, p. 2012/64. Directive as last amended by Directive 95/23/EC (OJ No L 243, 11. 10. 1995, p. 7).(8) OJ No L 55, 8. 3. 1971, p. 23. Directive as last amended by the 1994 Act of Accession.(9) OJ No L 26, 31. 1. 1977, p. 85. Directive as last amended by Directive 85/68/EC (OJ No L 332, 30. 12. 1995, p. 10).(10) OJ No L 268, 24. 9. 1991, p. 41. Directive as last amended by the 1994 Act of Accession.(11) OJ No L 268, 24. 9. 1991, p. 15. Directive as last amended by Directive 95/71/EC (OJ No L 332, 30. 12. 1995, p. 40).(12) OJ No L 317, 6. 11. 1981, p. 1. Directive as last amended by Directive 93/40/EEC (OJ No L 214, 24. 8. 1993, p. 31).(13) OJ No L 317, 6. 11. 1981, p. 16. Directive as last amended by Directive 93/40/EEC (OJ No L 214, 24. 8. 1993, p. 31).(14) OJ No L 214, 24. 8. 1993, p. 1.(15) OJ No L 373, 31. 12. 1990, p. 15.(16) See p. 10 of this Official Journal.(17) OJ No L 351, 2. 12. 1989, p. 34.(18) OJ No L 268, 24. 9. 1991, p. 56. Directive as last amended by Commission Decision 95/157/EC (OJ No L 103, 6. 5. 1995, p. 40).(19) OJ No L 373, 31. 12. 1990, p. 1. Directive as last amended by Directive 95/52/EC (OJ No L 265, 8. 11. 1995, p. 16).ANNEX >TABLE>

Summary: Prohibition on administering hormones (and other substances) to farm animals Prohibition on administering hormones (and other substances) to farm animals SUMMARY OF: Directive 96/22/EC — the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of ß-agonists WHAT IS THE AIM OF THE DIRECTIVE? It seeks to protect consumer health and maintain the quality of foodstuffs by creating a framework for the use of hormones intended for animals. KEY POINTS Substances The directive prohibits the administration of certain substances to farm animals to promote growth. The substances, listed in Annex II, are: thyrostatic* substances; stilbenes, stilbene derivatives, their salts and esters; oestradiol 17ß and its ester-like derivatives; beta-agonists* (prohibited but derogations possible under certain circumstances). There is also a list of provisionally prohibited substances in the directive’s Annex III: these comprise substances with an oestrogenic* (other than oestradiol 17ß and its ester-like derivatives), androgenic* or gestagenic* action (derogations possible). Directive 2003/74/EC amended Directive 96/22/EC, confirming the prohibition of hormones for growth promotion in animals. It also reduced substantially the circumstances under which oestradiol 17ß could be administered for other purposes to food-producing animals. Directive 2008/97/EC amended Directive 96/22/EC and limits the scope of Directive 96/22/EC only to food-producing animals, withdrawing the prohibitions for pet animals. As oestradiol 17β is not essential in the production of food-producing animals (because of available alternatives) and in view of its potential risks to human health, it is completely prohibited for use in food-producing animals. Therefore the temporary exemptions which were provided for the use of oestradiol 17β are not renewed. Prohibition The directive prohibits: the placing on the market of the substances listed above where they are to be administered to animals intended for human consumption (not including the therapeutic and zootechnical* exceptions); the placing on the market and slaughter of animals containing these substances or residues of these substances; the placing on the market of meats or products of animal origin containing these substances or residues of these substances; the holding of these substances on a farm. Exceptions Substances with a hormonal or thyrostatic action and beta-agonist substances may not be administered to farm animals. However, specific substances with hormonal action and beta agonists may be used for therapeutic and zootechnical purposes, provided their use is controlled. Imports The EU prohibits the import of animals, meat or products of animal origin from non-EU countries that authorise the administration of these substances for growth promotion. However, the EU prohibition does not apply where these countries are able to offer an equivalent guarantee for exports such as a segregated breeding system. FROM WHEN DOES THE DIRECTIVE APPLY? It has applied since 23 May 1996. EU countries had to incorporate it into national law by 1 July 1997. BACKGROUND For more information, see: Hormones in meat (European Commission). KEY TERMS Thyrostatic: medicines that reduce (or stabilise) the production of thyroid hormones. Oestrogenic: hormones that stimulate the development of female secondary sex characteristics (for example, lighter muscling and weight of cows than bulls), exert systemic effects such as growth and maturation of long bones and promote oestrus (i.e. a regularly occurring period of sexual receptivity) in female mammals. Androgenic: hormones that control the development and maintenance of masculine characteristics. Gestagenic: hormones that produce progestational (i.e. favouring gestation) effects in the uterus. Zootechnical: the technology of animal husbandry (domestication and selective breeding of animals). Beta-agonist: drugs that relax muscles (for example, when giving birth) by stimulating beta-adrenoceptors. MAIN DOCUMENT Council Directive 96/22/EC of 29 April 1996 concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of ß-agonists, and repealing Directives 81/602/EEC, 88/146/EEC and 88/299/EEC (OJ L 125, 23.5.1996, pp. 3-9) Successive amendments to Directive 96/22/EC have been incorporated into the original document. This consolidated version is of documentary value only. RELATED DOCUMENTS Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (OJ L 311, 28.11.2001, pp. 1-66) See consolidated version. last update 16.11.2017


EUR-Lex - 31996L0016 - EN Avis juridique important | 31996L0016 Council Directive 96/16/EC of 19 March 1996 on statistical surveys of milk and milk products Official Journal L 078 , 28/03/1996 P. 0027 - 0029 COUNCIL DIRECTIVE 96/16/EC of 19 March 1996 on statistical surveys of milk and milk productsTHE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 43 thereof,Having regard to the proposal from the Commission (1),Having regard to the opinion of the European Parliament (2),Whereas Council Directive 72/280/EEC of 31 July 1972 on the statistical surveys to be made by the Member States on milk and milk products (3) has been amended on several occasions; whereas, in the light of new amendments, it is in the interest of transparency to reformulate the provisions of the said Directive;Whereas in order to carry out its duties under the Treaty and under Community provisions on the common organization of the market in milk and milk products the Commission needs reliable information about the production and use of milk and regular, reliable, short-term information about the delivery of milk to enterprises which treat or process milk and about the production of milk products in the Member States;Whereas surveys on the production and use of milk on the farm should be conducted in accordance with uniform criteria and in greater detail, and monthly surveys should be made in all Member States in enterprises which process milk;Whereas, in order to obtain comparable results, common criteria should be fixed as regards the scope of the survey, the characteristics to be noted and the survey procedure;Whereas experience acquired in implementing the previous rules has shown that it would be useful to simplify the provisions, in particular by abolishing the requirement to provide weekly results;Whereas, in view of the growing importance of the milk-protein content of milk products the appropriate steps must be taken;Whereas, in order to facilitate implementation of the provisions of this Directive, it is appropriate to continue the close cooperation between the Member States and the Commission, particularly in the Standing Committee for Agricultural Statistics established by Decision 72/279/EEC (4),HAS ADOPTED THIS DIRECTIVE:Article 1 Member States:1. shall survey the survey units specified in Article 2 for the data specified in Article 4, and shall inform the Commission of the monthly, annual and triennial results;2. shall carry out annual surveys of the production of milk and its use among agricultural holdings as defined in accordance with the procedure laid down in Article 7;3. subject to the Commission's agreement, may use data from other official sources.Article 2 The surveys referred to in Article 1 (1) shall cover:1. undertakings or agricultural holdings which purchase whole milk or, in certain cases, milk products, either directly from agricultural holdings or from the undertakings referred to in point 2, with a view to transforming them into milk products;2. undertakings which collect milk or cream in order to transfer it in whole or in part, without any processing, to the undertakings referred to in point 1.Member States shall take all appropriate measures to prevent duplication of results as far as possible.Article 3 1. For the purpose of this Directive, 'milk` means the milk of cows, ewes, goats and buffaloes. The monthly surveys provided for in Article 4 (1) (a) shall cover only cow's milk and products manufactured exclusively from cow's milk.2. The list of milk products covered by the surveys shall be adopted in accordance with the procedure laid down in Article 7. That list may be amended in accordance with the same procedure.3. The standard definitions to be used for communicating the results for the various products shall be drawn up in accordance with the procedure laid down in Article 7.Article 4 1. The surveys referred to in Article 1 (1) must permit at least the information mentioned in points (a), (b) and (c) below to be provided.Questionnaires must be compiled in such a way as to avoid duplication.The information shall relate to:(a) monthly:(i) the quantity and fat content of the milk and cream collected and the protein content of the cows' milk collected;(ii) the quantity of certain fresh milk products processed and available for delivery and of certain manufactured dairy products;(b) annually:(i) the quantity, fat content and protein content of the available milk and cream;(ii) the quantity of fresh milk products which have been processed and which are available for delivery, and of other manufactured dairy products, broken down by type;(iii) the use of raw materials in the form of whole milk and skimmed milk and the amount of fats used in the manufacture of dairy products;(c) triennially (as from 31 December 1997):the number of the survey units referred to in Article 2, broken down by size class.2. With a view to analyzing, within three years of the entry into force of this Directive the possibility of extending the annual statistical information referred to in point (b) to include the protein content of the main milk products, Member States shall during that period conduct pilot surveys or studies on achieving that objective. In accordance with the procedure laid down in Article 7, the Commission shall establish a work programme for each of these three years.Member States shall submit annually to the Commission a report on the implementation of this programme, including the statistical data available and the information necessary for interpreting it.Article 5 1. Without prejudice to the second subparagraph, the surveys referred to in Article 1 (1) shall be exhaustive in the case of dairies accounting for at least 95 % of the cow's milk collected by the Member State, with the balance being estimated on the basis of representative samples or other sources.Member States may carry out the monthly surveys mentioned in Article 4 (1) (a) in the form of sample surveys. In that case the sampling error must not exceed 1 % of total national collection (with a confidence interval of 68 %).2. Member States shall take all appropriate measures to obtain comprehensive and sufficiently accurate results. They shall forward to the Commission in the form of a methodological report all information enabling the accuracy of the results transmitted to be assessed, in particular:(a) the questionnaires used;(b) the precautions taken to avoid double counting;(c) the methods used for transposing the data obtained from the questionnaire to Community tables.The methodological reports, the availability and reliability of data and any other matter related to the implementation of this Directive shall be examined once a year in the relevant working party of the Standing Committee for Agricultural Statistics. The first methodological report shall be forwarded to the Commission at the latest by the end of the year following the entry into force of this Directive.Article 6 1. Tables for the transmission of data shall be prepared in accordance with the procedure laid down in Article 7.These tables may be amended in accordance with the same procedure.2. Member States shall transmit the results referred to in paragraph 3, including data which are deemed confidential under national legislation or rules applied with regard to statistical confidentiality, in accordance with the provisions of Council Regulation (Euratom, EEC) No 1588/90 of 11 June 1990 on the transmission of data subject to statistical confidentiality to the Statistical Office of the European Communities (5).3. Member States shall send to the Commission as soon as possible after summarizing the information, and at the latest:(a) forty-five days after the end of the return month, the monthly results referred to in Article 4 (1) (a);(b) in June of the year following the return year:- the annual results referred to in Article 4 (1) (b);- the implementation report referred to in Article 4 (2);(c) in September of the year following the year of the return date, the results referred to in Article 1 (2) and Article 4 (1) (c).4. The Commission shall collate the information sent by the Member States and notify them of the overall results.Article 7 1. Where the procedure laid down in this Article is to be followed, the Chairman of the Standing Committee for Agricultural Statistics (hereinafter called 'the Committee`) shall refer the matter to the Committee, either on his own initiative or at the request of a representative of a Member State.2. The representative of the Commission shall submit to the Committee a draft of the 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 majority laid down in Article 148 (2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the Committee shall be weighted in the manner set out in that Article. The Chairman shall not vote.3. (a) The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the committee.(b) If the measures envisaged are not in accordance with the opinion of the Committee, or if no opinion is delivered, the Commission shall without delay submit to the Council a proposal relating to the measures to be taken. The Council shall act by a qualified majority.(c) If, on the expiry of a period of three months from the date of referral of the proposal to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission.Article 8 No later than 1 July 1999, the Commission shall submit to the Council a report on experience acquired in implementing this Directive. At the same time it shall submit, in particular, the results of the analysis referred to in Article 4 (2) accompanied where appropriate by proposals regarding the definitive period.Article 9 1. Directive 72/280/EEC shall be repealed with effect from 1 January 1997.2. The references to the repealed Directive 72/280/EEC shall be construed as referring to this Directive.Article 10 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 January 1997. They shall forthwith inform the Commission thereof.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 text of the main provisions of domestic law which they adopt in the field governed by this Directive.Article 11 This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Communities.Article 12 This Directive is addressed to the Member States.Done at Brussels, 19 March 1996.For the CouncilThe PresidentW. LUCHETTI(1) OJ No C 321, 1. 12. 1995, p. 6.(2) OJ No C 32, 5. 2. 1996.(3) OJ No L 179, 7. 8. 1972, p. 2. Directive as last amended by the 1994 Act of Accession.(4) OJ No L 179, 7. 8. 1972, p. 1.(5) OJ No L 151, 15. 6. 1990, p. 1.

Summary: Statistical surveys of dairy products Statistical surveys of dairy products SUMMARY OF: Directive 96/16/EC — statistical surveys of milk and milk products WHAT IS THE AIM OF THIS DIRECTIVE? It lays down EU-wide rules for the collection of statistics on milk* and milk products. It is designed to enable shorter and medium-term monitoring of the EU’s market for milk and milk products — this requires reliable, timely information on production and use of raw milk and of its components (including milk delivery for treatment or processing and the subsequent production of milk products). It repeals previous legislation (Directive 72/280/EEC) which had been amended on a number of occasions. KEY POINTS EU countries are responsible for data gathering and organising the surveys. The surveys cover the agricultural holdings producing milk and 2 groups of businesses: 1. businesses and agricultural holdings which purchase whole milk (or, in certain cases, milk products) from agricultural holdings or from the second group (below) with a view to transforming them into milk products; 2. businesses which collect milk and cream but do not process them, and then transfer them to the first group (above) for transformation. Depending on the information to be collected, EU countries must carry out the surveys on a monthly, an annual or a triennial basis. The directive sets out the deadlines by which EU countries should send the results of the various surveys to the European Commission (Eurostat). In 1997, the European Commission adopted Decision 97/80/EC laying down rules for implementing Directive 96/16/EC. The list of milk products covered by Directive 96/16/EC is set out in Annex I to Decision 97/80/EC. This annex also provides definitions for each of the products. Annex II to the decision provides specimens of the tables to be used for transmitting the data to Eurostat. Annex III contains the questionnaire on the compilation of milk statistics. The surveys must be exhaustive in the case of dairies accounting for at least 95% of the cows’ milk collected by each EU country, with the balance being estimated on the basis of representative samples or other sources. EU countries are responsible for ensuring comprehensive and sufficiently accurate results. Each year, EU countries must send a report to Eurostat including their questionnaire and accompanied by their methodology for transposing data to the tables sent to Eurostat. An expert group reviews the operation of the directive annually. FROM WHEN DOES THE DIRECTIVE APPLY? The directive has applied since 1 January 1997. It had to become law in the EU countries by 1 January 1997. KEY TERMS Milk: milk of cows, ewes, goats and buffaloes. MAIN DOCUMENT Council Directive 96/16/EC of 19 March 1996 on statistical surveys of milk and milk products (OJ L 78, 28.3.1996, pp. 27-29) Successive amendments to Directive 96/16/EC have been incorporated into the original document. This consolidated version is of documentary value only. RELATED DOCUMENTS Regulation (EC) No 1166/2008 of the European Parliament and of the Council of 19 November 2008 on farm structure surveys and the survey on agricultural production methods and repealing Council Regulation (EEC) No 571/88 (OJ L 321, 1.12.2008, pp. 14-34) See consolidated version. Commission Decision 97/80/EC of 18 December 1996 laying down provisions for the implementation of Council Directive 96/16/EC on statistical surveys of milk and milk products (OJ L 24, 25.1.1997, pp. 26-49) See consolidated version. last update 24.04.2018