Avis juridique important

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32003L0099

Directive 2003/99/EC of the European Parliament and of the Council of 17 November 2003 on the monitoring of zoonoses and zoonotic agents, amending Council Decision 90/424/EEC and repealing Council Directive 92/117/EEC

Official Journal L 325 , 12/12/2003 P. 0031 - 0040

Directive 2003/99/EC of the European Parliament and of the Councilof 17 November 2003on the monitoring of zoonoses and zoonotic agents, amending Council Decision 90/424/EEC and repealing Council Directive 92/117/EECTHE 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 European 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),Whereas:(1) Live animals and food of animal origin appear on the list in Annex I to the Treaty. Livestock farming and the placing on the market of food of animal origin constitute an important source of income for farmers. The implementation of veterinary measures aimed at raising the level of public and animal health in the Community assists the rational development of the farming sector.(2) The protection of human health against diseases and infections transmissible directly or indirectly between animals and humans (zoonoses) is of paramount importance.(3) Zoonoses transmissible through food may cause human suffering, as well as economic losses to food production and the food industry.(4) Zoonoses transmitted through sources other than food, especially from wild animal and pet animal populations, are also a matter of concern.(5) Council Directive 92/117/EEC of 17 December 1992 concerning measures for protection against specified zoonoses and specified zoonotic agents in animals and products of animal origin in order to prevent outbreaks of food-borne infections and intoxications(4) provided for the establishment of a monitoring system for certain zoonoses both at the level of Member States and at Community level.(6) With the assistance of the Community reference laboratory for the epidemiology of zoonoses, the Commission collects the results of monitoring yearly from Member States and compiles them. Publication of the results has taken place yearly since 1995. They provide a basis for the evaluation of the current situation concerning zoonoses and zoonotic agents. However, the data collection systems are not harmonised and therefore do not permit comparisons between Member States.(7) Other Community legislation provides for the monitoring and control of certain zoonoses in animal populations. In particular, Council Directive 64/432/EEC of 26 June 1964 on animal health problems affecting intra-Community trade in bovine animals and swine(5) deals with bovine tuberculosis and bovine brucellosis. Council Directive 91/68/EEC of 28 January 1991 on animal health conditions governing intra-Community trade in ovine and caprine animals(6) deals with ovine and caprine brucellosis. This Directive should not create any unnecessary duplication of those existing requirements.(8) Moreover, a future regulation of the European Parliament and of the Council on the hygiene of foodstuffs should cover specific elements necessary for prevention, control and monitoring of zoonoses and zoonotic agents and include specific requirements for the microbiological quality of food.(9) Directive 92/117/EEC provides for collection of data on human cases of zoonoses. The aim of Decision No 2119/98/EC of the European Parliament and of the Council of 24 September 1998 setting up a network for the epidemiological surveillance and control of communicable diseases in the Community(7) is to reinforce the collection of such data and to contribute to improving the prevention and control, in the Community, of communicable diseases.(10) The collection of data on the occurrence of zoonoses and zoonotic agents in animals, food, feed and humans is necessary to determine the trends and sources of zoonoses.(11) In its opinion on zoonoses adopted on 12 April 2000, the Scientific Committee on Veterinary Measures relating to Public Health considered that the measures in place at that time to control food-borne zoonotic infections were insufficient. It further considered that the epidemiological data that Member States were collecting were incomplete and not fully comparable. As a consequence, the Committee recommended improved monitoring arrangements and identified risk-management options. In particular, the Committee identified Salmonella spp., Campylobacter spp., verotoxigenic Escherichia coli (VTEC), Listeria monocytogenes, Cryptosporidium spp., Echinococcus granulosus/multilocularis and Trichinella spiralis as public health priorities.(12) It is therefore necessary to improve the existing monitoring and data collection systems established by Directive 92/117/EEC. Simultaneously, Regulation (EC) No 2160/2003 of the European Parliament and of the Council of 17 November 2003 on the control of salmonella and other specified food-borne zoonotic agents(8) will replace the specific control measures established by Directive 92/117/EEC. Directive 92/117/EEC should therefore be repealed.(13) The new framework for scientific advice and scientific support in matters of food safety set up by 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(9) should be used to collect and analyse the relevant data.(14) Where necessary to make data easier to compile and compare, monitoring should take place on a harmonised basis. This would make it possible to evaluate trends and sources of zoonoses and zoonotic agents within the Community. The data collected, together with data from other sources, should form the basis for risk assessment of zoonotic organisms.(15) Priority should be given to those zoonoses posing the greatest risk to human health. However, the monitoring systems should also facilitate the detection of emerging or newly emerging zoonotic diseases and new strains of zoonotic organisms.(16) The alarming emergence of resistance to antimicrobial agents (such as antimicrobial medicinal products and antimicrobial feed additives) is a characteristic that should be monitored. Provision should be made for such monitoring to cover not only zoonotic agents but also, in so far as they present a threat to public health, other agents. In particular, the monitoring of indicator organisms might be appropriate. Such organisms constitute a reservoir of resistance genes, which they can transfer to pathogenic bacteria.(17) In addition to general monitoring, specific needs may be recognised which may necessitate the establishment of coordinated monitoring programmes. Attention should be paid in particular to zoonoses listed in Annex I to Regulation (EC) No 2160/2003.(18) If thoroughly investigated, food-borne outbreaks of zoonoses provide the opportunity to identify the pathogen, the food vehicle involved and the factors in the food preparation and handling that contributed to the outbreak. It is therefore appropriate to make provision for such investigations and for close cooperation between the various authorities.(19) Transmissible spongiform encephalopathies are covered by Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies(10).(20) To ensure that information collected on zoonoses and zoonotic agents can be used effectively, appropriate rules should be laid down concerning the exchange of all relevant information. That information should be collected in Member States and transmitted to the Commission in the form of reports, which should be forwarded to the European Food Safety Authority and made available to the public in an appropriate way without delay.(21) The reports should be submitted on an annual basis. However, additional reports may be appropriate, when warranted by circumstances.(22) It may be appropriate to designate national and Community reference laboratories for giving guidance and assistance for analysis and testing in relation to zoonoses and zoonotic agents falling within the scope of this Directive.(23) Council Decision 90/424/EEC of 26 June 1990 on expenditure in the veterinary field(11) should be amended in so far as concerns the detailed rules governing the Community's financial contribution towards certain actions relating to the monitoring and control of zoonoses and zoonotic agents.(24) Appropriate procedures should be laid down for amending certain provisions of this Directive to take account of technical and scientific progress and for the adoption of implementing and transitional measures.(25) To take account of technical and scientific progress, close and effective cooperation should be ensured between the Commission and the Member States within the Standing Committee set up by Regulation (EC) No 178/2002.(26) Member States cannot, acting alone, collect comparable data to provide a basis for risk assessment of zoonotic organisms of significance at Community level. The collection of such data can better be achieved at Community level. The Community may therefore adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve those objectives. The responsibility for establishing and maintaining monitoring systems should lie with Member States.(27) 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(12),HAVE ADOPTED THIS DIRECTIVE:CHAPTER I INTRODUCTORY PROVISIONSArticle 1Subject matter and scope1. The purpose of this Directive is to ensure that zoonoses, zoonotic agents and related antimicrobial resistance are properly monitored, and that food-borne outbreaks receive proper epidemiological investigation, to enable the collection in the Community of the information necessary to evaluate relevant trends and sources.2. This Directive covers:(a) the monitoring of zoonoses and zoonotic agents;(b) the monitoring of related antimicrobial resistance;(c) the epidemiological investigation of food-borne outbreaks; and(d) the exchange of information related to zoonoses and zoonotic agents.3. This Directive shall apply without prejudice to more specific Community provisions on animal health, animal nutrition, food hygiene, communicable human diseases, health and safety in the workplace, gene technology and transmissible spongiform encephalopathies.Article 2DefinitionsFor the purposes of this Directive, the following definitions shall apply:1. the definitions laid down in Regulation (EC) No 178/2002, and2. the following definitions:(a) "zoonosis" means any disease and/or infection which is naturally transmissible directly or indirectly between animals and humans;(b) "zoonotic agent" means any virus, bacterium, fungus, parasite or other biological entity which is likely to cause a zoonosis;(c) "antimicrobial resistance" means the ability of micro-organisms of certain species to survive or even to grow in the presence of a given concentration of an antimicrobial agent, that is usually sufficient to inhibit or kill micro-organisms of the same species;(d) "food-borne outbreak" means an incidence, observed under given circumstances, of two or more human cases of the same disease and/or infection, or a situation in which the observed number of cases exceeds the expected number and where the cases are linked, or are probably linked, to the same food source;(e) "monitoring" means a system of collecting, analysing and disseminating data on the occurrence of zoonoses, zoonotic agents and antimicrobial resistance related thereto.Article 3General obligations1. Member States shall ensure that data on the occurrence of zoonoses and zoonotic agents and antimicrobial resistance related thereto are collected, analysed and published without delay in accordance with the requirements of this Directive and of any provisions adopted pursuant to it.2. Each Member State shall designate a competent authority or competent authorities for the purposes of this Directive and notify the Commission thereof. If a Member State designates more than one competent authority, it shall:(a) notify the Commission of the competent authority that will act as a contact point for contacts with the Commission; and(b) ensure that the competent authorities cooperate so as to guarantee the proper implementation of the requirements of this Directive.3. Each Member State shall ensure that effective and continuous cooperation based on free exchange of general information and, where necessary, of specific data, is established between the competent authority or authorities designated for the purposes of this Directive and:(a) the competent authorities for the purposes of Community legislation on animal health;(b) the competent authorities for the purposes of Community legislation on feed;(c) the competent authorities for the purposes of Community legislation on food hygiene;(d) the structures and/or authorities referred to in Article 1 of Decision No 2119/98/EC;(e) other authorities and organisations concerned.4. Each Member State shall ensure that the relevant officials of the competent authority or competent authorities referred to in paragraph 2 undertake suitable initial and ongoing training in veterinary science, microbiology or epidemiology, as necessary.CHAPTER II MONITORING OF ZOONOSES AND ZOONOTIC AGENTSArticle 4General rules on monitoring of zoonoses and zoonotic agents1. Member States shall collect relevant and comparable data in order to identify and characterise hazards, to assess exposures and to characterise risks related to zoonoses and zoonotic agents.2. Monitoring shall take place at the stage or stages of the food chain most appropriate to the zoonosis or zoonotic agent concerned, that is:(a) at the level of primary production; and/or(b) at other stages of the food chain, including in food and feed.3. Monitoring shall cover zoonoses and zoonotic agents listed in Annex I, Part A. Where the epidemiological situation in a Member State so warrants, zoonoses and zoonotic agents listed in Annex I, Part B shall also be monitored.4. Annex I may be amended in accordance with the procedure referred to in Article 12(2) to add zoonoses or zoonotic agents to, or delete them from, the lists therein, taking account in particular of the following criteria:(a) their occurrence in animal and human populations, feed and food;(b) the gravity of their effects for humans;(c) their economic consequences for animal and human health care and for feed and food businesses;(d) epidemiological trends in animal and human populations, feed and food.5. Monitoring shall be based on the systems in place in Member States. However, where necessary to make data easier to compile and compare, detailed rules for the monitoring of zoonoses and zoonotic agents listed in Annex I may be laid down in accordance with the procedure referred to in Article 12(2) and taking into consideration other Community rules laid down in the fields of animal health, food hygiene and communicable human diseases.Such detailed rules shall lay down minimum requirements for the monitoring of certain zoonoses or zoonotic agents. They may, in particular, specify:(a) the animal population or subpopulations or stages in the food chain to be covered by monitoring;(b) the nature and type of data to be collected;(c) case definitions;(d) sampling schemes to be used;(e) laboratory methods to be used in testing; and(f) the frequency of reporting, including guidelines for reporting between local, regional and central authorities.6. When considering whether to propose detailed rules in accordance with paragraph 5 to harmonise the routine monitoring of zoonoses and zoonotic agents, the Commission shall give priority to zoonoses and zoonotic agents listed in Part A of Annex I.Article 5Coordinated monitoring programmes1. If data collected through routine monitoring in accordance with Article 4 are not sufficient, coordinated monitoring programmes concerning one or more zoonoses and/or zoonotic agents may be established in accordance with the procedure referred to in Article 12(2). Coordinated monitoring programmes may be established, especially when specific needs are identified, to assess risks or to establish base-line values related to zoonoses or zoonotic agents at the level of Member States or at Community level.2. Where a coordinated monitoring programme is established, special reference shall be made to zoonoses and zoonotic agents in animal populations referred to in Annex I to Regulation (EC) No 2160/2003.3. Minimum rules concerning the establishment of coordinated monitoring programmes are laid down in Annex III.Article 6Food business operators' duties1. Member States shall ensure that, when food business operators carry out examinations for the presence of zoonoses and zoonotic agents subject to monitoring under Article 4(2), they:(a) keep the results and arrange for the preservation of any relevant isolate for a period to be specified by the competent authority; and(b) communicate results or provide isolates to the competent authority on request.2. Detailed rules for the implementation of this Article may be laid down in accordance with the procedure referred to in Article 12(2).CHAPTER III ANTIMICROBIAL RESISTANCEArticle 7Monitoring of antimicrobial resistance1. Member States shall ensure, in accordance with the requirements set out in Annex II, that monitoring provides comparable data on the occurrence of antimicrobial resistance in zoonotic agents and, in so far as they present a threat to public health, other agents.2. Such monitoring shall supplement the monitoring of human isolates conducted in accordance with Decision No 2119/98/EC.3. Detailed rules for the implementation of this Article shall be laid down in accordance with the procedure referred to in Article 12(2).CHAPTER IV FOOD-BORNE OUTBREAKSArticle 8Epidemiological investigation of food-borne outbreaks1. Member States shall ensure that, when a food business operator provides information to the competent authority pursuant to Article 19(3) of Regulation (EC) No 178/2002, the foodstuff involved, or an appropriate sample of it, is preserved in order not to impede its investigation in a laboratory or the investigation of any food-borne outbreak.2. The competent authority shall investigate food-borne outbreaks in cooperation with the authorities referred to in Article 1 of Decision No 2119/98/EC. The investigation shall provide data on the epidemiological profile, the foodstuffs potentially implicated and the potential causes of the outbreak. The investigation shall include, as far as possible, adequate epidemiological and microbiological studies. The competent authority shall transmit to the Commission (which shall send it to the European Food Safety Authority) a summary report of the results of the investigations carried out, containing the information referred to in Part E of Annex IV.3. Detailed rules concerning the investigation of food-borne outbreaks may be laid down in accordance with the procedure referred to in Article 12(2).4. Paragraphs 1 and 2 shall apply without prejudice to Community provisions on product safety, early warning and response systems for the prevention and control of communicable human diseases, food hygiene and the general requirements of food law, in particular those concerning emergency measures and procedures for withdrawing food and feed from the market.CHAPTER V EXCHANGE OF INFORMATIONArticle 9Assessment of trends and sources of zoonoses, zoonotic agents and antimicrobial resistance1. Member States shall assess trends and sources of zoonoses, zoonotic agents and antimicrobial resistance in their territory.Each Member State shall transmit to the Commission every year by the end of May a report on trends and sources of zoonoses, zoonotic agents and antimicrobial resistance, covering the data collected pursuant to Articles 4, 7 and 8 during the previous year. Reports, and any summaries of them, shall be made publicly available.Reports shall also contain the information referred to in Article 3(2)(b) of Regulation (EC) No 2160/2003.Minimum requirements concerning the reports are laid down in Annex IV. Detailed rules concerning the assessment of those reports, including the formats and the minimum information that they must include, may be laid down in accordance with the procedure referred to in Article 12(2).Where the circumstances warrant it, the Commission may request specific additional information and the Member States shall submit reports to the Commission upon such request, or on their own initiative.2. The Commission shall send the reports referred to in paragraph 1 to the European Food Safety Authority, which shall examine them and publish by the end of November a summary report on the trends and sources of zoonoses, zoonotic agents and antimicrobial resistance in the Community.When preparing the summary report, the European Food Safety Authority may take into consideration other data provided for in the framework of Community legislation, such as:- Article 8 of Directive 64/432/EEC,- Article 14(2) of Directive 89/397/EEC(13),- Article 24 of Decision 90/424/EEC,- Article 4 of Decision No 2119/98/EC.3. Member States shall provide the Commission with the results of coordinated monitoring programmes established in accordance with Article 5. The Commission shall send the results to the European Food Safety Authority. The results, and any summaries of them, shall be made publicly available.CHAPTER VI LABORATORIESArticle 10Community and national reference laboratories1. One or more Community reference laboratories for the analysis and testing of zoonoses and zoonotic agents and antimicrobial resistance related thereto may be designated in accordance with the procedure referred to in Article 12(2).2. Without prejudice to the relevant provisions of Decision 90/424/EEC, the responsibilities and tasks of the Community reference laboratories, in particular with regard to coordination of their activities and those of the national reference laboratories, shall be laid down in accordance with the procedure referred to in Article 12(2).3. Member States shall designate national reference laboratories for each field where a Community reference laboratory has been established and inform the Commission thereof.4. Certain responsibilities and tasks of the national reference laboratories, in particular with regard to coordination of their activities and those of relevant laboratories in the Member States, may be laid down in accordance with the procedure referred to in Article 12(2).CHAPTER VII IMPLEMENTATIONArticle 11Amendments to the Annexes and transitional or implementing measuresAnnexes II, III and IV may be amended and any appropriate transitional or implementing measures adopted in accordance with the procedure referred to in Article 12(2).Article 12Committee procedure1. The Commission shall be assisted by the Committee on the Food Chain and Animal Health instituted by Regulation (EC) No 178/2002 or, where appropriate, by the Committee set up under Decision No 2119/98/EC.2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.3. The Committee shall adopt its Rules of Procedure.Article 13Consultation of the European Food Safety AuthorityThe Commission shall consult the European Food Safety Authority on any matter within the scope of this Directive that could have a significant impact on public health, in particular before proposing any amendment to Annexes I or II or before establishing any coordinated monitoring programme in accordance with Article 5.Article 14Transposition1. Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive by 12 April 2004. They shall forthwith inform the Commission thereof.They shall apply those measures by 12 June 2004.When Member States adopt those measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.2. Member States shall communicate to the Commission the text of the provisions of national law that they adopt in the field covered by this Directive.CHAPTER VIII FINAL PROVISIONSArticle 15RepealDirective 92/117/EEC shall be repealed with effect from 12 June 2004.However, measures which Member States have adopted pursuant to Article 8(1) of Directive 92/117/EEC and those implemented in accordance with Article 10(1) thereof and plans approved in accordance with Article 8(3) thereof shall remain in force until corresponding control programmes have been approved in accordance with Article 5 of Regulation (EC) No 2160/2003.Article 16Amendment of Decision 90/424/EECDecision 90/424/EEC is hereby amended as follows:1. Article 29 is replaced by the following:"Article 291. Member States may seek a Community financial contribution for the monitoring and control of the zoonoses specified in the Annex, Group 2, in the framework of the provisions referred to in Article 24(2) to (11).2. As regards control of zoonoses, the Community financial contribution shall be introduced as part of a national control programme referred to in Article 5 of Regulation (EC) No 2160/2003 of the European Parliament and of the Council of 17 November 2003 on the control of salmonella and other specified food-borne zoonotic agents(14). The level of Community financial participation shall be fixed at a maximum of 50 % of costs incurred for the implementation of mandatory control measures."2. the following Article is inserted:"Article 29aMember States may seek from the Community the financial contribution referred to in Article 29(2) for a national plan which was approved on the basis of Directive 92/117/EEC, until the date on which corresponding control programmes have been approved in accordance with Article 6 of Regulation (EC) No 2160/2003."3. In the Annex, the following indents shall be added to the list under Group 2:"- Campylobacteriosis and agents thereof- Listeriosis and agents thereof- Salmonellosis (zoonotic salmonella) and agents thereof- Trichinellosis and agents thereof- Verotoxigenic Escherichia coli."Article 17Entry into forceThis Directive shall enter into force on the day of its publication in the Official Journal of the European Union.Article 18AddresseesThis Directive is addressed to the Member States.Done at Brussels, 17 November 2003.For the European ParliamentThe PresidentP. CoxFor the CouncilThe PresidentG. Alemanno(1) OJ C 304 E, 30.10.2001, p. 250.(2) OJ C 94, 18.4.2002, p. 18.(3) Opinion of the European Parliament of 15 May 2002 (OJ C 180 E, 31.7.2003, p. 161), Council common position of 20 February 2003 (OJ C 90 E, 15.4.2003, p. 9) and position of the European Parliament of 19 June 2003 (not yet published in the Official Journal).(4) OJ L 62, 15.3.1993, p. 38. Directive as last amended by Regulation (EC) No 806/2003 (OJ L 122, 16.5.2003, p. 1).(5) OJ 121, 29.7.1964, p. 1977. Directive as last amended by Commission Regulation (EC) No 1226/2002 (OJ L 179, 9.7.2002, p. 13).(6) OJ L 46, 19.2.1991, p. 19. Directive as last amended by Commission Decision 2003/708/EC (OJ L 258, 10.10.2003, p. 11).(7) OJ L 268, 3.10.1998, p. 1.(8) See page 1 of this Official Journal.(9) OJ L 31, 1.2.2002, p. 1.(10) OJ L 147, 31.5.2001, p. 1. Regulation as last amended by Commission Regulation (EC) No 1494/2002 (OJ L 225, 22.8.2002, p. 3).(11) OJ L 224, 18.8.1990, p. 19. Decision as last amended by Decision 2001/572/EC (OJ L 203, 28.7.2001, p. 16).(12) OJ L 184, 17.7.1999, p. 23.(13) Council Directive 89/397/EEC of 14 June 1989 on the official control of foodstuffs (OJ L 186, 30.6.1989, p. 23).(14) OJ L 325, 12.12.2003, p. 1.ANNEX IA. Zoonoses and zoonotic agents to be included in monitoring- brucellosis and agents thereof- campylobacteriosis and agents thereof- echinococcosis and agents thereof- listeriosis and agents thereof- salmonellosis and agents thereof- trichinellosis and agents thereof- tuberculosis due to Mycobacterium bovis- verotoxigenic Escherichia coliB. List of zoonoses and zoonotic agents to be monitored according to the epidemiological situation1. Viral zoonoses- calicivirus- hepatitis A virus- influenza virus- rabies- viruses transmitted by arthropods2. Bacterial zoonoses- borreliosis and agents thereof- botulism and agents thereof- leptospirosis and agents thereof- psittacosis and agents thereof- tuberculosis other than in point A- vibriosis and agents thereof- yersiniosis and agents thereof3. Parasitic zoonoses- anisakiasis and agents thereof- cryptosporidiosis and agents thereof- cysticercosis and agents thereof- toxoplasmosis and agents thereof4. Other zoonoses and zoonotic agentsANNEX IIRequirements for monitoring of antimicrobial resistance pursuant to Article 7A. General requirementsMember States must ensure that the monitoring system for antimicrobial resistance provided for in Article 7 provides at least the following information:1. animal species included in monitoring;2. bacterial species and/or strains included in monitoring;3. sampling strategy used in monitoring;4. antimicrobials included in monitoring;5. laboratory methodology used for the detection of resistance;6. laboratory methodology used for the identification of microbial isolates;7. methods used for the collection of the data.B. Specific requirementsMember States must ensure that the monitoring system provides relevant information at least with regard to a representative number of isolates of Salmonella spp., Campylobacter jejuni and Campylobacter coli from cattle, pigs and poultry and food of animal origin derived from those species.ANNEX IIICoordinated monitoring programmes as referred to in Article 5When a coordinated monitoring programme is established, at least the following characteristics of the programme must be defined:- its purpose;- its duration;- its geographical area or region;- the zoonoses and/or zoonotic agents concerned;- the type of samples and other data units requested;- minimum sampling schemes;- the type of laboratory testing methods;- the tasks of competent authorities;- the resources to be allocated;- the estimation of its costs and how they will be covered; and- the method and time of reporting the results.ANNEX IVRequirements for the reports to be submitted pursuant to Article 9(1)The report referred to in Article 9(1) must provide at least the following information. Parts A to D apply to reports on monitoring carried out in accordance with Article 4 or 7. Part E applies to reports on monitoring carried out in accordance with Article 8.A. Initially the following must be described for each zoonosis and zoonotic agent (later only changes have to be reported):(a) monitoring systems (sampling strategies, frequency of sampling, kind of specimen, case definition, diagnostic methods used);(b) vaccination policy and other preventive actions;(c) control mechanism and, where relevant, programmes;(d) measures in case of positive findings or single cases;(e) notification systems in place;(f) history of the disease and/or infection in the country.B. Each year the following must be described:(a) relevant susceptible animal population (together with the date the figures relate to):- number of herds or flocks,- total number of animals, and- where relevant, methods of production involved;(b) number and general description of the laboratories and institutions involved in monitoring.C. Each year the following details on each zoonotic agent and data category concerned must be described with their consequences:(a) changes in the systems already described;(b) changes in previously described methods;(c) results of the investigations and of further typing or other method of characterisation in laboratories (for each category reported on separately);(d) national evaluation of the recent situation, the trend and the sources of infection;(e) relevance as zoonotic disease;(f) relevance to human cases, as a source of human infection, of findings in animals and food;(g) control strategies recognised that could be used to prevent or minimise transmission of the zoonotic agent to humans;(h) if necessary, any specific action decided in the Member State or suggested for the Community as a whole on the basis of the recent situation.D. Reporting of results of examinationsResults shall be given by stating the number of epidemiological units investigated (flocks, herds, samples, batches) and the number of positive samples according to the case definition. The results shall, when necessary, be presented in a way which shows the geographical distribution of the zoonosis or the zoonotic agent.E. For food-borne outbreak data:(a) total number of outbreaks over a year;(b) number of human deaths and illnesses in these outbreaks;(c) the causative agents of the outbreaks, including, where possible, serotype or other definitive description of the agents. Where the identification of the causative agent is not possible, the reason for such unidentifiability should be stated;(d) foodstuffs implicated in the outbreak and other potential vehicles;(e) identification of the type of place where the foodstuff incriminated was produced/purchased/acquired/consumed;(f) contributory factors, for example, deficiencies in food processing hygiene.


Avis juridique important

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31990L0207

Commission Directive 90/207/EEC of 4 April 1990 amending the Second Directive 82/434/EEC on the approximation of the laws of the Member State relating to methods of analysis necessary for checking the composition of cosmetic products

Official Journal L 108 , 28/04/1990 P. 0092 - 0101 Finnish special edition: Chapter 13 Volume 19 P. 0177  Swedish special edition: Chapter 13 Volume 19 P. 0177

*****COMMISSION  DIRECTIVE  of 4 April 1990  amending the Second Directive 82/434/EEC on the approximation of the laws of the Member State relating to methods of analysis necessary for checking the composition of cosmetic products  (90/207/EEC)  THE COMMISSION OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community,  Whereas Second Commission Directive 82/434/EEC of 14 May 1982 on the approximation of the laws of the Member States relating to methods of analysis for checking the composition of cosmetic products (1) lays down a common method of analysis for the identification and determination of free formaladehyde;  Whereas, in the light of new scientific and technical data, it has proved to be necessary to amend this method of analysis;  Whereas the measures provided for in this Directive are in conformity with the opinion of the Committee on the Adaptation to Technical Progress of the Directives on the Removal of Technical Barriers to Trade in the Cosmetic Products sector,  HAS ADOPTED THIS DECISION:  Article 1  Chapter IV of the Annex to Directive 82/434/EEC shall be replaced by the text set out in the Annex hereto.  Article 2  Member States shall bring into force the laws, regulations or administrative provisions necessary to comply with this Directive not later than 31 December 1990. They shall forthwith inform the Commission thereof.  The provisions adopted under the first paragraph shall refer expressly to this Directive.  Article 3  This Directive is addressed to the Member States.  Done at Brussels, 4 April 1990.  For the Commission  Karel VAN MIERT  Member of the Commission  (1) OJ No L 185, 30. 6. 1982, p. 1.  ANNEX  'IV. IDENTIFICATION AND DETERMINATION OF FREE FORMALDEHYDE  1.2 // 1.   // PURPOSE AND SCOPE   //   // This method describes the identification and two determination according to the presence or not of formaldehyde donors. It is applicable to all cosmetic products.   // 1.1.   // Identification   // 1.2.  // General determination by pentane-2,4-dione colorimetry  //   // This method applies when formaldehyde is used alone or with other preservatives that are not formaldehyde donors.  //   // Where this is not the case, and if the result exceeds the maximum permitted concentration, the following method of confirmation must be used.   // 1.3.   // Determination in the presence of formaldehyde donors   //   // In the method mentioned above (1.2), during the derivization, the formaldehyde donors split and lead to results that are too high (combined and polymerized formaldehyde)   //   // It is necessary to separate the free formaldehyde by liquid chromatography.   // 2.   // DEFINITION   //   // The free formaldehyde content of the sample determined according to this method is expressed as percentage by mass.   // 3.  // IDENTIFICATION   // 3.1.   // Principle   //   // Free and combined formaldehyde in a sulphuric acid medium turns Schiff's reagent pink or mauve.   // 3.2.   // Reagents   //   // All reagents should be of analytical purity and the water has to be demineralized.   // 3.2.1.   // Fuchsin;   // 3.2.2.  // Sodium sulphite hydrated at 7H2O;   // 3.2.3.  // Concentrated hydrochloric acid (d=1,19);   // 3.2.4.  // Sulphuric acid, about 1M;   // 3.2.5.   // Schiff's reagent:   //   // 100 mg of fuchsin (3.2.1) is weighed into a beaker and dissolved in 75 ml of water at 80 °C. After cooling, add 2,5 g of sodium sulphite (3.2.2). Make up to 100 ml.   //  // Use within two weeks.   // 3.3.   // Procedure   // 3.3.1.  // Weigh 2 g of the sample in a 10-ml beaker.   // 3.3.2.  // Add two drops of sulphuric acid (3.2.4) and 2 ml of Schiff's reagent (3.2.5) . This reagent must be absolutely colourless when it is used.   //   // Shake and leave to stand for five minutes.   // 3.3.3.   // If a pink or mauve tint is observed within the five minutes, the formaldehyde is present in excess of 0,01 % and is to be determined by the free and combined method (4) and, if necessary, by procedure (5).  // 4.   // GENERAL DETERMINATION BY PENTANE-2,4-DIONE COLORIMETRY   // 4.1.   // Principle   //   // Formaldehyde reacts with pentane-2,4-dione in the presence of ammonium acetate to form 3,5-diacetyl-1,4-dihydrolutidine. This is extracted with butan-1-ol and the absorbance of the extract is measured at 410 nm.  // 4.2.   // Reagents   //   // All reagents should be of analytical purity and the water has to be demineralized.  // 4.2.1.   // Anhydrous ammonium, acetate;   // 4.2.2.  // Concentrated acetic acid, d204 = 1,05;   // 4.2.3.  // Pentane-2,4-dione freshly distilled under reduced pressure 25 mm Hg 25° - it should not exhibit any absorption at 410 nm.  // 4.2.4.   // Butan-1-ol;   // 4.2.5.   // Hydrochloric acid, 1 M;   // 4.2.6.   // Hydrochloric acid, approximately 0,1 M;  // 4.2.7.   // Sodium hydroxide, 1 M;   // 4.2.8.   // Starch solution freshly prepared according to the European Pharmacopoeia (1 g/50 ml water), 2nd edition 1980, part I-VII-1-1;   // 4.2.9.   // 37 to 40 % w/v formaldehyde;  // 4.2.10   // Standard iodine solution, 0,05 M;   // 4.2.11.  // Standard sodium thiosulphate solution, 0,1 M;   // 4.2.12  // Pentane-2,4-dione reagent:   //   // In a 1 000 ml volumetric flask dissolve:   //   // - 150 g ammonium acetate (4.2.1),   //   // - 2 ml pentane-2,4-dione (4.2.3),   //  // - 3 ml acetic acid (4.2.2).   //   // Make up to 1 000 ml with water (pH of solution about 6,4).   //   // This reagent must be freshly prepared;   // 4.2.13.   // Reagent (4.2.12) without pentane-2,4-dione;   // 4.2.14  // Formaldehyde-standard: stock solution   //   // Pour 5 g of formaldehyde (4.2.9) into a 1 000-ml volumetric flask and make up to 1 000 ml with water.   //   // Determine the strength of this solution as follows:   //   // Remove 10,00 ml; add 25,00 ml of a standard iodine solution (4.2.10) and 10,00 ml of sodium hydroxide solution (4.2.7).   //   // Allow to stand for five minutes.   //   // Acidify with 11,00 ml of HCl (4.2.5) and determine the excess iodine with a standard sodium thiosulphate solution (4.2.11), using starch solution (4.2.8) as indicator.   //   // 1 ml of 0,05 M iodine (4.2.10) consumed is equivalent to 1,5 mg formaldehyde;   // 4.2.15.  // Formaldehyde-standard: diluted solution   //   // Dilute the formaldehyde stock solution successively 1/20 and then 1/100 with water.   //   // 1 ml of this solution contains about 1 mg of formaldehyde.   //   // Calculate the exact content.   // 4.3.   // Apparatus   // 4.3.1.   // Standard laboratory apparatus;   // 4.3.2.   // Phase separation filter, Whatman 1 PS (or equivalent);   // 4.3.3.   // Centrifuge;  // 4.3.4.   // Water-bath set at 60 °C;   // 4.3.5.  // Spectrophotometer;   // 4.3.6.   // Glass cells with an optical path of 1 cm.   // 4.4.   // Procedure   // 4.4.1.  // Sample solution   //   // Into a 100-ml volumetric flask weigh to within 0,001 g a quantity (in g) of the test sample corresponding to a presumed quantity of formaldehyde of about 150 mg.   //   // Make up to 100 ml with water and mix (solution S).   //   // (Check that the pH is close to 6; if not, dilute in the hydrochloric acid solution (4.2.6).)  //  // To a 50-ml Erlenmeyer flask add:   //   // - 10,00 ml of the solution S,   //   // - 5,00 ml pentane-2,4-dione reagent (4.2.12).   //   // - demineralized water to a final volume of 30 ml.   // 4.4.2.   // Reference solution   //  // Possible interference due to background colour in the test sample is eliminated by the use of this reference solution:  //   // To a 50-ml Erlenmeyer flask add:   //   // - 10,00 ml S solution,   //   // - 5,00 ml reagent (4.2.13),   //   // - demineralized water to a final volume of 30 ml.   // 4.4.3.  // Blank test   //   // To a 50-ml Erlenmeyer flask add:   //  // - 5,0 ml pentane-2,4-dione reagent (4.2.12),   //   // - demineralized water to a final volume of 30 ml.   // 4.4.4.  // Determination   // 4.4.4.1.   // Shake the mixtures from 4.4.1, 4.4.2 and 4.4.3. Immerse the Erlenmeyer flasks in a water-bath at 60 °C for exactly 10 minutes. Allow to cool for two minutes in a bath of iced water.   // 4.4.4.2   // Transfer into 50-ml separating funnels containing 10 ml of butan-1-ol (4.2.4). Rinse each flask with 3 to 5 ml of water. Shake the mixture vigorously for exactly 30 seconds. Allow it to separate.   // 4.4.4.3.   // Filter the butan-1-ol phase into the measurement cells (4.3.2) through a phase-separation filter. Centrifuging (3 000 gn for five minutes) may also be used.   // 4.4.4.4.   // Measure the absorbance A1 at 410 nm of the extract of the sample solution from 4.4.1 against the extract of the reference solution 4.4.2.   // 4.4.4.5.  // Similarly measure the absorbance A2 of the extract of the blank solution from 4.4.3 against butan-1-ol.   //   // N B: All these operations must be carried out within 25 minutes from the moment when the Erlenmeyer flasks are placed in the water bath at 60 °C.  // 4.4.5.   // Calibration curve   // 4.4.5.1.  // Into a 50-ml Erlenmeyer flask place:   //   // - 5,00 ml of the diluted standard solution from 4.2.15,   //   // - 5,00 ml of the pentane-2,4-dione reagent (4.2.12),   //   // - demineralized water to a final volume of 30 ml.   // 4.4.5.2.  // Continue as described in 4.4.4 and measure the absorbance against butan-1-ol (4.2.4).   // 4.4.5.3.   // Repeat the procedure with 10, 15, 20 and 25 ml of the diluted standard solution (4.2.15).   // 4.4.5.4.   // To obtain the zero value (corresponding to the coloration of the reagents) proceed as in 4.4.4.5.   // 4.4.5.5.   // Construct the calibration curve after subtraction of the zero value from each of the absorbances obtained in 4.4.5.1 and 4.4.5.3. Beer's Law is valid up to 30 mg formaldehyde.   // 4.5.   // Calculations  // 4.5.1.   // Subtract A2 from A1 and read off from the calibration curve (4.4.5.5) the amount C, in mg, of formaldehyde in the sample solution (4.4.1).   // 4.5.2.  // Calculate the formaldehyde content of sample (% m/m) with the aid of the following formula:  1.2.3 //   // formaldehyde content in % =  // C 103 ; m 1.2 //  // siere:   //   // m = mass of tie test portion in 9.  1.2 // 4.6.   // Repeatability (1)   //   // For a formaldehyde content of 0,2 % the difference between the results of two determinations in parallel carried out on the same sample should not exceed 0,005 % for determination by pentane-2,4-dione colorimetry.   //   // If the determination of free formaldehyde leads to results greater than the maximum concentrations provided for in Directive 76/768/EEC, i.e.:  //   // (a) between 0,05 % and 0,2 % in a non-labelled product;   //   // (b) greater than 0,2 % in the product, whether or not labelled the procedure described in 5 below must be applied.   // 5.   // DETERMINATION IN THE PRESENCE OF FORMALDEHYDE DONORS   // 5.1.   // Principle   //   // The separate formaldehyde is transformed into a yellow lutidinic derivative by a reaction with the pentane-2,4-dione in a post-column reactor and the derivative obtained is detected by absorbance at 420 nm.   // 5.2.   // Reagents   //   // All reagents should be of analytical purity and the water has to be demineralized.   // 5.2.1.   // HPLC grade water or water of equivalent quality;   // 5.2.2.   // Anhydrous ammonium, acetate;   // 5.2.3.   // Concentrated acetic acid;   // 5.2.4.   // Pentane-2,4-dione (kept at 4 °C);   // 5.2.5.  // Anhydrous disodium phosphate;   // 5.2.6.   // 85 % orthophosphoric acid (d = 1,7);   // 5.2.7.   // HPLC grade methanol;   // 5.2.8.   // Dichloromethane;   // 5.2.9.   // 37 to 40 % w/v formaldehyde;   // 5.2.10.   // Sodium hydroxide, 1 M;   // 5.2.11.   // Hydrochloric acid, 1 M;   // 5.2.12.  // Hydrochloric acid, 0,002 M;   // 5.2.13.   // Starch solution freshly prepared according to the European Pharmacopoeia (see 4.2.8);   // 5.2.14.   // Standard iodine solution, 0,05 M;   // 5.2.15.   // Standard sodium thiosulphate solution, 0,1 M;   // 5.2.16.   // Mobile phase:  //   // Aqueous solution of disodium phosphate (5.2.5), 0,006 M adjusted to pH 2,1 with orthophosphoric acid (5.2.6);  // 5.2.17.   // Post-column reagent:   //   // In a 1 000 ml volumetric flask dissolve:   //   // - 62,5 g ammonium acetate (5.2.2),   //   // - 7,5 ml acetic acid (5.2.3),   //   // - 5 ml pentane-2,4-dione (5.2.4).   //   // Make up to 1 000 ml with water (5.2.1).   //   // Keep this reagent away from the light.   //   // Conservation time: maximum three days at 25 °C.   //   // No change in colour should be observed;  // 5.2.18.   // Formaldehyde standard: stock solution   //  // Pour 10 g of formaldehyde (5.2.9) into a 1 000 ml volumetric flask and make up to 1 000 ml with water.   //  // Determine the strength of this solution as follows:   //  // Remove 5,00 ml; add 25,00 ml of the standard iodine solution (5.2.14) and 10,00 ml of the sodium hydroxide solution (5.2.10).   //   // Allow to stand for five minutes.   //  // Acidify with 11,00 ml of HCl (5.2.11) and titrate the excess standard iodine solution with standard sodium thiosulphate solution (5.2.15), using starch solution (5.2.13) as indicator.   //   // 1 ml of iodine solution (5.2.14) is  (1) ISO 5725.   // 5.2.19.   // Formaldehyde standard: diluted solution  //   // Dilute the stock solution to 1/100th of its initial strength in the mobile phase (5.2.16).   //   // 1 ml of this solution contrains about 37 mg formaldehyde.   //  // Calculate the exact content.   // 5.3.   // Apparatus  // 5.3.1.   // Standard laboratory apparatus;   // 5.3.2.  // HPLC pump, pulsation-free;   // 5.3.3.   // Low-pressure pulsation-free pump for the reagent (or a second HPLC pump);  // 5.3.4.   // Injection valve with a 10 ml loop;   // 5.3.5.  // Post-column reactor with the following components:   //  // + one 1-litre three-neck flask,   //   // + one 1-litre flask heater,   //   // + two Vigreux columns with a minimum of 10 plates, two air-cooled,   //   // + stainless steel tube (for heat exchange) 1,6 mm - internal diameter 0,23 mm, length = 400 mm,   //   // + Teflon tube 1,6 mm - internal diameter 0,30 mm, length 5 m (French knitting) see Appendix 1),   //  // + one T-piece without any dead volume (Valco or equivalent),   //   // + three unions without any dead volume  //   // Or: one post-column module Applied Biosystems PCRS 520 or equivalent fitted with a 1-ml reactor;  // 5.3.6.  // Membrane filter, pore size 0,45 mm;   // 5.3.7.  // SEP-PAKR C18 cartridge or equivalent;   // 5.3.8.  // Ready-to-use colulmns:   //   // - Bischoff hypersil RP 18 (type NC reference C 25.46 1805) (5 mm, length = 250 mm, internal diameter = 4,6 mm),   //   // - or Dupont, Zorbax ODS (5 mm, length = 250 mm, internal diameter = 4,6 mm),   //  // - or Phase SEP, spherisorb ODS 2 (5mm, length = 250 mm, internal diameter = 4,6 mm);   // 5.3.9   // Pre-column   //  // Bischoff K1 hypersil RP 18 (reference K1 G 6301 1805)   //  // (5mm, length = 10 mm, or equivalent).   // 5.3.10   // The column and pre-column are connected by means of an Ecotube system (reference A 15020508 Bischoff) or equivalent.  // 5.3.11.   // Assemble the apparatus (5.3.5) as shown in the block diagram in Appendix 2.   //   // The connections after the injection value must be kept as short as possible. In this case, the stainless-steel tube between the reactor outlet and the detector inlet is intended to cool the mixture prior to detection and the temperature in the detector is unknown but constant;   // 5.3.12.   // UV visible detector;   // 5.3.13.  // Recorder;   // 5.3.14.   // Centrifuge;   // 5.3.15  // Ultrasonic bath;   // 5.3.16.   // Vibrating stirrer (vortex or equivalent).   // 5.4.   // Procedure   // 5.4.1.  // Calibration curve   //   // This is produced by plotting peak heights as a function of the concentration of formaldehyde standard: diluted.   //   // Prepare the standard solutions by diluting the formaldehyde reference solution (5.2.19) with the mobile phase (5.2.16):   //   // - 1,00 ml of solution (5.2.19) diluted to 20,00 ml (about 185 mg/100 ml)   //   // - 2,00 ml of solution (5.2.19) diluted to 20,00 ml (about 370 mg/100 ml)  //   // - 5,00 ml of solution (5.2.19) diluted to 25,00 ml (about 740 mg/100 ml)   //   // - 5,00 ml of solution (5.2.19) diluted to 20,00 ml (about 925 mg/100 ml)   //   // The standard solutions are kept for one hour at laboratory temperature and must be freshly prepared.   //   // The linearity of the calibration curve is good for concentrations between 1,00 and 15,00 mg/ml.  // 5.4.2.   // Preparation of the samples   // 5.4.2.1.  // Emulsions (creams, make-up base, eyeliners)   //   // Into a stoppered 100-ml flask weigh to the nearest 0,001 g a quantity of test sample (m g) corresponding to a presumed quantity of 100 mg of formaldehyde. Add 20,00 ml dichloromethane (5.2.8) and 20,00 ml hydrochloric acid (5.2.12), accurately measured. Mix with the vibrating stirrer (5.3.16) and by means of the ultrasonic bath (5.3.15). Separate the two phases by centrifuging (3 000 gn for two minutes). Meanwhile, wash a cartridge (5.3.7) with 2 ml methanol (5.2.7), then condition with 5 ml water (5.2.1).   //   // Pass 4 ml of the aqueous phase of the extract through the conditioned cartridge, discard the first 2 ml and recover the following fraction.   // 5.4.2.2.   // Lotions, shampoos   //   // Weigh into a stoppered 100-ml flask to the nearest 0,001 g a quantity of test sample (m g) corresponding to a presumed quantity of about 500 mg of formaldehyde.   //   // Make up to 100 ml with the mobile phase (5.2.16).   //   // Filter the solution through a filter (5.3.6) and inject or pass it through a cartridge (5.3.7) conditioned as before (5.4.2.1). All the solutions must be injected immediately after preparation.  // 5.4.3.   // Chromatographic conditions   //   // - Flowrate of the mobile phase: 1 ml/min,   //   // - Reagent flowrate: 0,5 ml/min,   //   // - Total flowrate at the detector outlet: 1,5 ml/min,   //   // - Injected volume: 10 ml,   //   // - Elution temperature: In the case of difficult separations, immerse the column in a bath of melting ice: wait for the temperature to stabilize (15-20 min),   //   // - Temperature of post-column reaction: 100 °C,   //   // - Detection: 420 nm.   //   // NB: The entire chromatographic system and post-column must be flushed out with water after use (5.2.1). Where the system is not used for more than two days, this flushing must be followed by flushing with methanol (5.2.7). Before reconditioning the system pass water through it to avoid recrystallization.  // 5.5.   // Calculation   //  // Emulsions: (5.4.2.1):   //   // Formaldehyde content in % (m/m):  1.2.3.4 //   // C ; 10-6 ; 100 5 m   // =   // C ; 10-4 5 m  1.2 //   // Lotions, siampoos:   //   // In tiis psase tie formthla vepsomes:  1.2.3.4 //   // PS ; 10-6 ; 100 m   // =  // C ; 10-4 m  1.2 //   // siere:   //   // m = mass of tie sample analysed in g (5.4.2.1),   //   // PS = formaldeivde psonpsentration in mg/100 ml read off from the calibration curve (5.4.1).   // 5.6.   // Repeatability (1)   //   // For a content of 0,05 % of formaldehyde the difference between the results of two determinations in parallel carried out on the same sample should not exceed 0,001 %.   //   // For a content of 0,2 % of formaldehyde the difference between the results of two determinations in parallel carried out on the same sample should not exceed 0,005 %. equivalent to 1,5 mg formaldehyde;  (1) ISO 5725.  Appendix 1  INTRUCTION FOR "FRENCH KNITTING"  ACCESSORIES REQUIRED  - One wooden bobbin:  external diameter 5 cm with a hole of 1,5 cm diameter made through the centre. Insert four steel nails (as shown in Figures 1 and 2). The distance between two nails must be 1,8 cm and they must be 0,5 cm from the hole,  - one rigid needle (of the crotchet-hook type) to loop the Teflon tube,  - 5 m of 1,6 mm Teflon tube, internal diameter 0,3 mm.  PROCEDURE  To start off the "French knitting", the Teflon tube must be threaded from the top of the bobbin to the bottom via the central hole (leaving around 10 cm of tube protruding from the bottom of the bobbin, enabling the chain to be pulled through during the knitting process); then wind the tube around the four nails in turn as shown in Figure 3.  The top and bottom of the French knitting will be protected by metal rings and compression screws; take care not to crush the Teflon when pulling tight. Wind the tube around each nail for a second turn and make the 'stitches' as follows:  - lift the lower tube over the upper tube with the hook (see Figure 4). Repeat this process on each of the nails in order (1, 2, 3, 4 in an anti-clockwise direction), until 5 m or the desired length of knitting is produced.  Leave around 10 cm of tube to close the chain. Thread the tube through each of the four loops and pull gently, to close up the end of the chain.  NB: French knitting manufactured for post column reactors is available on the market (Supelco). Schematic diagram of the bobbin  1.2.3 // Figure 1 Figure 2  //  // Figure 3 First tube Figure 4 Second tube To form a "stitch", lift the lower tube (unbroken line) up over the second tube (dotted line) Figure 5  Appendix 2  1.2 // 1   // = HPLC pump   // 2   // = Injection valve  // 3   // = Column with pre-column   // 4   // = Reagent pump  // 5   // = T-piece without dead volume   // 5'   // = T-piece (Vortex)   // 6-6'   // = Union without dead volume   // 7  // = 'French knitting'   // 7'   // = Reactor   // 8   // = Three-neck flask with boiling water   // 9   // = Flask heater  // 10   // = Coolant   // 11   // = Stainless steel heat-exchanger tube   // 11'   // = Heat exchanger   // 12  // = Visible UV detector   // 13   // = PCRS 520 post-column module  5.3.5  5.3.6  Eluent Reagents'Keep this reagent away from the light .   //  Conservation time : maximum three days at 25 *C .   //  No change in colour should be observed;  5.2.18 .  Formaldehyde standard : stock solution   //  Pour 10 g of formaldehyde ( 5.2.9 ) into a 1 000 ml volumetric flask and make up to 1 000 ml with water .   //  Determine the strength of this solution as follows :   //  Remove 5,00 ml; add 25,00 ml of the standard iodine solution ( 5.2.14 ) and 10,00 ml of the sodium hydroxide solution ( 5.2.10 ).   //  Allow to stand for five minutes .   //  Acidify with 11,00 ml of HCl ( 5.2.11 ) and titrate the excess standard iodine solution with standard sodium thiosulphate solution ( 5.2.15 ), using starch solution ( 5.2.13 ) as indicator .   //  1 ml of iodine solution ( 5.2.14 ) is equivalent to 1,5 mg  ( 1 ) ISO 5725 .  5.2.19 .  Formaldehyde standard : diluted solution   //  Dilute the stock solution to 1/100th of its initial strength in the mobile phase ( 5.2.16 ).   //  1 ml of this solution contrains about 37 mg formaldehyde .  //  Calculate the exact content .  5.3 .  Apparatus  5.3.1 .  Standard laboratory apparatus;  5.3.2 .  HPLC pump, pulsation-free;  5.3.3 .  Low-pressure pulsation-free pump for the reagent ( or a second HPLC pump );  5.3.4 .  Injection valve with a 10 *l loop;  5.3.5 .  Post-column reactor with the following components :   //  + one 1-litre three-neck flask,   //  + one 1-litre flask heater,   //  + two Vigreux columns with a minimum of 10 plates, two air-cooled,   //  + stainless steel tube ( for heat exchange ) 1,6 mm _ internal diameter 0,23 mm, length = 400 mm,   //  + Teflon tube 1,6 mm _ internal diameter 0,30 mm, length 5 m ( French knitting ) see Appendix 1 ),   //  + one T-piece without any dead volume ( Valco or equivalent ),  //  + three unions without any dead volume   //  Or : one post-column module Applied Biosystems PCRS 520 or equivalent fitted with a 1-ml reactor;  5.3.6 .  Membrane filter, pore size 0,45 *m;  5.3.7 .  SEP-PAKR C18 cartridge or equivalent;  5.3.8 .  Ready-to-use colulmns :   //  _ Bischoff hypersil RP 18 ( type NC reference C 25.46 1805 ) ( 5 *m, length = 250 mm, internal diameter = 4,6 mm ),   //  _ or Dupont, Zorbax ODS ( 5 *m, length = 250 mm, internal diameter = 4,6 mm ),   //  _ or Phase SEP, spherisorb ODS 2 ( 5*m, length = 250 mm, internal diameter = 4,6 mm );  5.3.9  Pre-column   //  Bischoff K1 hypersil RP 18 ( reference K1 G 6301 1805 )   //  ( 5*m, length = 10 mm, or equivalent ).  5.3.10  The column and pre-column are connected by means of an Ecotube system ( reference A 15020508 Bischoff ) or equivalent .  5.3.11 .  Assemble the apparatus ( 5.3.5 ) as shown in the block diagram in Appendix 2 .   //  The connections after the injection value must be kept as short as possible . In this case, the stainless-steel tube between the reactor outlet and the detector inlet is intended to cool the mixture prior to detection and the temperature in the detector is unknown but constant;  5.3.12 .  UV visible detector;  5.3.13 .  Recorder;  5.3.14 .  Centrifuge;  5.3.15  Ultrasonic bath;  5.3.16 .  Vibrating stirrer ( vortex or equivalent ).  5.4 .  Procedure  5.4.1 .  Calibration curve   //  This is produced by plotting peak heights as a function of the concentration of formaldehyde standard : diluted .   //  Prepare the standard solutions by diluting the formaldehyde reference solution ( 5.2.19 ) with the mobile phase ( 5.2.16 ):  //  _ 1,00 ml of solution ( 5.2.19 ) diluted to 20,00 ml ( about 185 *g/100 ml )   //  _ 2,00 ml of solution ( 5.2.19 ) diluted to 20,00 ml ( about 370 *g/100 ml )   //  _ 5,00 ml of solution ( 5.2.19 ) diluted to 25,00 ml ( about 740 *g/100 ml )   //  _ 5,00 ml of solution ( 5.2.19 ) diluted to 20,00 ml ( about 925 *g/100 ml )   //  The standard solutions are kept for one hour at laboratory temperature and must be freshly prepared .   //  The linearity of the calibration curve is good for concentrations between 1,00 and 15,00 *g/ml .  5.4.2 .  Preparation of the samples  5.4.2.1 .  Emulsions ( creams, make-up base, eyeliners )   //  Into a stoppered 100-ml flask weigh to the nearest 0,001 g a quantity of test sample ( m g ) corresponding to a presumed quantity of 100 *g of formaldehyde . Add 20,00 ml dichloromethane ( 5.2.8 ) and 20,00 ml hydrochloric acid ( 5.2.12 ), accurately measured . Mix with the vibrating stirrer ( 5.3.16 ) and by means of the ultrasonic bath ( 5.3.15 ). Separate the two phases by centrifuging ( 3 000 gn for two minutes ). Meanwhile, wash a cartridge ( 5.3.7 ) with 2 ml methanol ( 5.2.7 ), then condition with 5 ml water ( 5.2.1 ).   //  Pass 4 ml of the aqueous phase of the extract through the conditioned cartridge, discard the first 2 ml and recover the following fraction .  5.4.2.2 .  Lotions, shampoos   //  Weigh into a stoppered 100-ml flask to the nearest 0,001 g a quantity of test sample ( m g ) corresponding to a presumed quantity of about 500 *g of formaldehyde .   //  Make up to 100 ml with the mobile phase ( 5.2.16 ).   //  Filter the solution through a filter ( 5.3.6 ) and inject or pass it through a cartridge ( 5.3.7 ) conditioned as before ( 5.4.2.1 ). All the solutions must be injected immediately after preparation .  5.4.3 .  Chromatographic conditions   //  _ Flowrate of the mobile phase : 1 ml/min,   //  _ Reagent flowrate : 0,5 ml/min,   //  _ Total flowrate at the detector outlet : 1,5 ml/min,   //  _ Injected volume : 10 *l,   //  _ Elution temperature : In the case of difficult separations, immerse the column in a bath of melting ice : wait for the temperature to stabilize ( 15-20 min ),   //  _ Temperature of post-column reaction : 100 *C,   //  _ Detection : 420 nm .   //  NB : The entire chromatographic system and post-column must be flushed out with water after use ( 5.2.1 ). Where the system is not used for more than two days, this flushing must be followed by flushing with methanol ( 5.2.7 ). Before reconditioning the system pass water through it to avoid recrystallization .  5.5 .  Calculation   //  Emulsions : ( 5.4.2.1 ):   //  Formaldehyde content in % ( m/m ):  1.2.3.4 //  C  10-6  100 5 m  =  C  10-4 5 m  1.2 // ******* ********   ** **** **** *** ******* *******  1.2.3.4 // *  // 10-6  100 m  =  C  10-4 m  1.2 // *****   *  **** ** *** ****** ******** ** *    * ************ ************* **  *g/100 ml read off from the calibration curve ( 5.4.1 ).  5.6 .  Repeatability ( 1 )   //  For a content of 0,05 % of formaldehyde the difference between the results of two determinations in parallel carried out on the same sample should not exceed 0,001 %.   //  For a content of 0,2 % of formaldehyde the difference between the results of two determinations in parallel carried out on the same sample should not exceed 0,005 %. formaldehyde;  ( 1 ) ISO 5725 .  Appendix 1  INTRUCTION FOR "FRENCH KNITTING"  ACCESSORIES REQUIRED  _ One wooden bobbin :  external diameter 5 cm with a hole of 1,5 cm diameter made through the centre . Insert four steel nails ( as shown in Figures 1 and 2 ). The distance between two nails must be 1,8 cm and they must be 0,5 cm from the hole,  _ one rigid needle ( of the crotchet-hook type ) to loop the Teflon tube,  _ 5 m of 1,6 mm Teflon tube, internal diameter 0,3 mm .  PROCEDURE  To start off the "French knitting", the Teflon tube must be threaded from the top of the bobbin to the bottom via the central hole ( leaving around 10 cm of tube protruding from the bottom of the bobbin, enabling the chain to be pulled through during the knitting process ); then wind the tube around the four nails in turn as shown in Figure 3 .  The top and bottom of the French knitting will be protected by metal rings and compression screws; take care not to crush the Teflon when pulling tight . Wind the tube around each nail for a second turn and make the "stitches' as follows :  _ lift the lower tube over the upper tube with the hook ( see Figure 4 ). Repeat this process on each of the nails in order ( 1, 2, 3, 4 in an anti-clockwise direction ), until 5 m or the desired length of knitting is produced .  Leave around 10 cm of tube to close the chain . Thread the tube through each of the four loops and pull gently, to close up the end of the chain .  NB : French knitting manufactured for post column reactors is available on the market ( Supelco ).  Schematic diagram of the bobbin  1.2.3Figure 1 Figure 2  Figure 3 First tube Figure 4 Second tube To form a "stitch", lift the lower tube ( unbroken line ) up over the second tube ( dotted line ) Figure 5  Appendix 2  1.21  = HPLC pump  2  = Injection valve  3  = Column with pre-column  4  = Reagent pump  5  = T-piece without dead volume  5'  = T-piece ( Vortex )  6-6'  = Union without dead volume  7  = "French knitting'  7'  = Reactor  8  = Three-neck flask with boiling water  9  = Flask heater  10  = Coolant  11  = Stainless steel heat-exchanger tube  11'  = Heat exchanger  12  = Visible UV detector  13  = PCRS 520 post-column module  5.3.5  5.3.6  Eluent Reagents'