The importance of a response to every notification
1. The Codex Alimentarius is the record of Codex Standards and of acceptances or other notifications by Member Countries or international organizations to which competence in the matter has been transferred by their Member States. It is revised regularly to take account of the issue of new or amended standards and the receipt of notifications. It is important that governments respond to every issue of new or amended standards. Governments should aim at giving formal acceptance to the standards. If acceptance or free circulation cannot be given unconditionally, the deviations or conditions, and the reasons, can be included in the response. Early and regular responses will ensure that the Codex Alimentarius can be kept up to date so as to serve as an indispensable reference for governments and international traders.
2. Governments should ensure that the information in the Codex Alimentarius reflects the up to date position. When changing national laws or practices the need for a notification to the Codex Secretariat should always be kept in mind.
3. The Codex procedure for elaboration of standards enables governments to participate at all stages. Governments should be able to make an early response to the issue of a Codex standard and should do their utmost to be ready to do so.
The Codex Alimentarius: not a substitute for, or alternative to, referring to national legislation
4. Every countrys laws and administrative procedures contain provisions which it is essential to understand and comply with. It is usually the practice to take steps to obtain copies of relevant legislation and/or to obtain professional advice about compliance. The Codex Alimentarius is a comparative record of the substantive similarities and differences between Codex Standards and corresponding national legislation. The Codex Standard will not normally deal with general matters of human, plant or animal health or with trade marks. The language which is required on labels will be a matter for national legislation and so will import licences and other administrative procedures.
5. The responses by governments should show clearly which provisions of the Codex Standard are identical to, similar to or different from, the related national requirements. General statements that national laws must be complied with should be avoided or accompanied by details of national provisions which require attention. Judgement will sometimes be required where the national law is in a different form or where it has different provisions.
Obligations under the Acceptance Procedure
6. The obligations which a country undertakes under the acceptance procedure are included in paragraph 4 of the General Principles. Paragraph 4.A(i)(a) provides for free distribution of conforming products, 4.A(i)(b) with the need to ensure that products which do not conform may not be distributed under the name and description laid down. Paragraph 4.A(i)(c) is a general requirement not to hinder the distribution of sound products, except for matters relating to human, plant or animal health, not specifically dealt with in the standard. Similar provisions are included in Acceptance with Specified Deviations.
7. The essential difference between acceptances and notifications of free distribution is that a country which accepts, undertakes to enforce the Codex standard and to accept all the obligations set out in the General Principles subject to any specified deviations.
8. The Codex Committee on General Principles (CCGP) and the Commission (CAC) have reviewed the acceptance procedure and notifications by governments on a number of occasions. While recognizing that difficulties can arise from time to time in reconciling the obligations of the acceptance procedure with the laws and administrative procedures of a Member Country, the CCGP and the CAC have determined that the obligations are essential to the work and status of the CAC and that they should not be weakened in any way. The purpose of these guidelines therefore is to assist governments when they are considering how, in the light of the objectives of the acceptance procedure, to respond to Codex Standards.
The return of the response
9. The principal decision which is required is whether to notify an acceptance according to one of the methods prescribed, or non acceptance as provided for in 4.B. Free distribution (4.A(iii)) does not carry with it the obligation to prevent non conforming products from being circulated, and it may be useful in cases where there is no corresponding national standard and no intention to introduce one.
The need for an informed, responsible judgement when comparing the Codex Standard with national laws
10. There will be some occasions when the detail in the Codex Standard is identical with national laws. Difficulties will arise however when national laws are in a different form, contain different figures or no figures at all, or in cases where there may be no standard in the country which corresponds in substance to the Codex Standard. The authority responsible for notifying the response to the CAC is urged to do its best to overcome any such difficulties by the exercise of its best endeavours and to respond, after such consultations as may be appropriate with the national organizations. The grounds on which the judgement has been based can be made clear in the notification. It may well be that they will not be such as to justify an acceptance, because of the obligations to stop the distribution of non conforming products, but a statement of free circulation should be possible on the basis of the facts and practices of each case. If there was a court decision or change in the law or practice subsequently, an amending response should be made.
11. A presumptive standard is one which is assumed to be the standard in the absence of any other. (A presumption in law is the assumption of the truth of anything until the contrary is proved.) Some countries have said that a Codex MRL is the presumptive limit for a pesticide residue. Countries may be able and willing to regard a Codex Standard as the presumptive standard in cases where there is no corresponding standard, code of practice or other accepted expression of the nature, substance or quality of the food. A country need not apply the presumption to all the provisions of the standard if the details of its additives, contaminants, hygiene or labelling rules are different from those in the standard. In such a case the provisions in the Codex Standard defining the description, essential composition and quality factors relating to the specified name and description could still be the presumptive standard for those matters.
12. The justification for regarding the Codex Standard as a presumptive standard is the fact that it is the minimum standard for a food elaborated in the CAC so as to ensure a sound, wholesome product free from adulteration, correctly labelled and presented. (General Principles, Paragraph 3.) The word minimum does not have any pejorative connotations: it simply means the level of quality and soundness of a product judged by consensus to be appropriate for trade internationally and nationally.
13. Whether a presumptive standard would merit an acceptance would depend on whether the country concerned could say that non conforming products could not be distributed under the same name and description laid down in the standard. However it would enable a declaration of free circulation to be made and countries are asked to give the idea serious consideration.
Format and Content of Codex Standards
14. This section, together with the name of the standard and the name and description laid down in the labelling section, should be examined in order to assess whether the obligations of the acceptance procedure can properly be accepted.
Description, essential composition and quality factors
15. These sections will define the minimum standard for the food. They will be the most difficult to address unless by chance the details are virtually identical (i.e. ignoring significant matters of editorial expression or format). However, a country which has taken part in the elaboration of the standard either by attending the meetings or by sending comments under the Step Procedure has, no doubt, consulted national organizations on the extent to which the draft provisions in the standard would be acceptable nationally. This factual information needs to be turned into a formal response when the standard is sent out for acceptance. Countries are asked to do their best to exercise an informal judgement on lines discussed in Paragraph 7 above. Some of the quality criteria e.g. allowances for defects may represent good manufacturing practice or be left to trade contracts. This will have to be taken into account. A free distribution response ought to be possible in most cases.
16. The food additives included in the standard have been assessed and cleared by JECFA. The Commodity Committee and the CCFAC have assessed technological need and safety in use. If national laws are different, all the detailed differences should be reported. It should be borne in mind, however, that the aim of international food standardization work is to harmonize policies and attitudes as much as possible. Therefore every effort should be made to keep deviations to the minimum.
17. If national limits apply they should be quoted if not the same as those laid down in the Codex Standard. Where general laws about safety, health or nature of the food apply, the limits quoted in the standard could properly be regarded as representing those which are unavoidable in practice and within safety limits.
Hygiene and Weights and Measures
18. If national requirements are different they should be reported.
19. The General Standard for the Labelling of Prepackaged Foods represents the international consensus on information to be included on the labels of all foods.
20. Governments are exhorted to use the General Standard as a basis for their national legislation and to keep differences to an absolute minimum especially those of detail or minutiae. Governments should observe the footnote to the Scope section and should ensure that all compulsory provisions relating to presentation of information which are additional to, and different from, those in the standard should be notified. Any other compulsory provisions in national legislation should also be notified if they are not provided for in the Codex standard. The labelling provisions in Codex standards include sections of the revised General Standard by reference. When accepting a Codex commodity standard, a country which has already accepted and responded to the General Standard can then refer to the terms of that acceptance in any subsequent responses. As much specific information as is relevant and helpful should be given. In particular, this should include the name and description relating to the food, the interpretation of any special requirements relating to the law or custom of the country, any additional details about presentation of the mandatory information and detailed differences if any in the labelling requirements e.g. in relation to class names, declaration of added water, declaration of origin. It will be assumed that the language(s) in which the particulars should be given will be as indicated by national legislation or custom.
Methods of Analysis and Sampling
21. The obligations which a country assumes in accepting the following Codex Defining Methods of Analysis included in Codex standards are as follows:
(a) Codex Defining Methods of Analysis (Type I) are subject to acceptance by governments just as are the provisions which they define and which form part of Codex standards.
Full acceptance of a Codex Defining Method means the acceptance that the value provided for in a Codex standard is defined by means of the Codex method. In determining compliance with the value in the Codex standard, governments undertake to use the Codex Defining Method, especially in cases of disputes involving the results of analysis.
Non acceptance of Codex Defining Method or acceptance of Codex standards with substantive deviations in the Codex Defining Methods means acceptance of the Codex standard with specified deviation.
(b) The acceptance of Codex standards containing Codex Reference Methods of Analysis (Type II) means the recognition that Codex Reference Methods are methods the reliability of which has been demonstrated on the basis of internationally acceptable criteria. They are, therefore, obligatory for use, i.e. subject to acceptance by governments, in disputes involving the results of analysis. Non acceptance of the Codex Reference Method or acceptance of Codex standards with substantive deviations in the Codex Reference Methods for use in disputes involving methods of analysis, should be taken to mean acceptance of the Codex standard with specified deviation.
(c) The acceptance of Codex standards containing Codex Alternative Approved Methods of Analysis (Type III) means the recognition that Codex Alternative Approved Methods are methods the reliability of which has been demonstrated in terms of internationally acceptable criteria. They are recommended for use in food control, inspection or for regulatory purposes.
Non acceptance of a Codex Alternative Approved Method does not constitute a deviation from the Codex standard.
(d) Since the reliability of the Tentative Methods (Type IV) has not yet been endorsed by the Codex Committee on Methods of Analysis and Sampling on the basis of the internationally accepted criteria, it follows that they cannot be regarded as final Codex methods. Type IV methods may, eventually become Type I, II or III methods with the resultant implications regarding the acceptance of Codex methods. Type IV methods are, therefore, not recommended as Codex methods until their reliability has been recognized by the CCMAS. They may be included in draft Codex standards or in Codex standards provided their non approved status is clearly indicated.
22. Governments are urged to respond to every issue of Codex standards. The inclusion of responses in the Codex Alimentarius will enable the CAC and Member Governments to address the question of closer approximation of international and national requirements. Governments are urged to take the Codex standard fully into consideration when changing their national laws. The Codex Alimentarius will always be an invaluable reference for governments and for international traders although national legislation must always be consulted and complied with.