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The New Approach in Setting Product Standards for Safety, Environmental Protection and Human Health

Appendix B
Technical Specifications in Legislation: New Approach and other methods

Legislation is normally considered as an activity that primarily involves legislators, governments and civil servants. However, in certain forms of legislation there are areas of a highly technical nature where a wider form of expertise is required.

In 1985, the Council adopted a Resolution introducing a new approach to the problem of how to access this wider form of expertise. The "New Approach" uses Standards developed under mandate to CEN¹ as a means of developing necessary technical guidance to supplement Community legislation. This involves the delegation of forming what is intended to form part of legally binding legislation to a private organisation. However, the problem of the inclusion of highly technical requirements in legislation is not new, and other methods of addressing the problem, which do not involve delegation to private organisations, are also used. This paper describes some of these other approaches.

1. Transport of Dangerous Goods

The regulation of the transport of dangerous goods is an area where much of the regulation is of a highly technical nature. The regulations governing this transport are elaborated in the context of a United Nations Committee, in which UN Member States take part. In 1956, the United Nations Economic and Social Council (ECOSOC) published the first edition of the UN Recommendations concerning the Transport of Dangerous Goods.The UN CETDG updates these Recommendations², and the Eleventh Revised Edition was adopted in 1999.These Recommendations include a series of detailed test methods and specifications that are in effect very similar to standards³. These specifications include test methods to determine the effects of dangerous goods, including a series of tests for explosive properties.The Recommendations also contain rules for the classification and labelling of dangerous goods, as well as detailed specifications for containers for these goods.

The UN CETDG is a working group where the United Nations Economic Commission for Europe (UN ECE) provides the Meeting Secretariat. The relevant national authority represents member countries. Other countries, not taking an active role in the elaboration of the Recommendations have Observer status. Industry and other organisations can take part in these meetings with the status of observers. Agreement on UN Transport Recommendations follows a formal vote.The UN recommendations ("Red book") are adopted on the basis of a majority vote from countries that are formally considered as active members of the Committee⁴. Countries with observer status only do not have voting rights for adoption of these Recommendations. Adoption of the regional ADR⁵ and RID Recommendations (where again the UN ECE provides the Meeting Secretariat) is again obtained by the result of a majority vote, where all signatory countries⁶ are eligible to vote.

The UN regulations for transport of dangerous goods by road and rail have subsequently been adopted as the basis for European legislation⁷.

2. Codex Alimentarius

The regulation of food safety is similarly an area where much of the regulation is of a highly technical nature. The food standards programme is elaborated in the context of a United Nations Committee, in which UN Member States take part. There are two UN organisations concerned with nutrition, the Food and Agriculture Organisation (FAO) and the World Health Organisation. (WHO), and, as a result, many initiatives in this area are taken by Joint Committees of the two organisations. A Joint FAO/WHO Food Standards Programme was established in 1962. This programme, also known as the Codex Alimentarius Commission, met for its first session in 1963. This intergovernmental body is comprised of representatives of more than 120 member nations⁸.

The Codex Alimentarius develops food safety standards that serve as a reference for international food trade. Its primary mission is to protect the health of consumers and to ensure fair practices in international food trade.To this end the Codex Alimentarius Commission adopts standards for commodities, codes of practice and maximum limits for additives, contaminants, pesticides residues and veterinary drugs, which are prepared by specialised committees and task forces.

The General Subject Committees are the Codex Committee on Food Additives and Contaminants (CCFAC), the Codex Committee on Pesticide Residues (CCPR) and the Codex Committee on Residues of Veterinary Drugs in Foods (CCRVDF).These Codex Alimentarius Committees are assisted by a number of working groups such as the Joint FAO/WHO Expert Committee on Food Additives (JECFA⁾ and the Joint FAO/WHO Meeting on Pesticides Residues (JMPR).

Since the conclusion of the Uruguay Round in 1994, the role of Codex Alimentarius Standards has been strengthened. The World Trade Organisation Agreement on Sanitary and Phytosanitary Measures considers that WTO members applying the Codex Alimentarius standards meet their obligations under this Agreement.

The Member States of the EU are all members of the Codex Alimentarius. The European Commission is an observer.The European Commission and the Member States attempt to present joint comments on issues discussed in Codex Committees which are within the competence of Community legislation. These comments are presented in EU position papers co-ordinated by the Directorate General for Consumer and Health Protection acts as the contact point and work.

3. OECD Test Guidelines Programme

In the area of chemicals control, the first initiatives towards the systematic collection of data on chemicals were taken in the OECD⁹. In 1974, a Ministerial Meeting adopted a number of Recommendations, including one on the pre-marketing assessment of the potential effects of chemicals on man and the environment¹⁰. A natural consequence of this Recommendation was that agreed testing methods would be need to be developed to achieve this goal, and the OECD Test Guidelines Programme was started in 1977. There was also concern that this aim should be achieved "without unnecessary impediments to trade and industrial development in the countries directly involved", and this resulted in the adoption of a Decision on Mutual Acceptance of Data (MAD) in 1981. The basis for the MAD agreement is that tests carried out according to OECD Test Guidelines¹¹ and according to Good Laboratory Practice (GLP) are 1regarded as acceptable data by OECD Member States irrespective of where the tests were originally carried out.

The OECD Guidelines for the Testing of Chemicals are a collection of the most widely used internationally agreed testing methods used by government, industry and independent laboratories to identify and characterise potential hazards of new and existing chemical substances (including biocides and agricultural pesticides) and chemical preparations/mixtures. They cover tests for physicalchemical properties of chemicals, human health effects, environmental effects, as well as degradation and accumulation in the environment.

Since they were first adopted in 1981, the OECD Guidelines for the testing of chemicals represent a basic set of tools that are primarily for use in regulatory safety testing and subsequent chemical and chemical product notification and chemical registration. The Test Guidelines are updated as required in order to keep pace with progress in science. In addition, new Test Guidelines are developed and agreed upon, based on specific needs identified by OECD Member countries. OECD-wide networks of governmental National Co-ordinators and national experts provide the opportunity for input from scientists in government, academia and industry. Broad acceptance and recognition of the Test Guidelines as the international standard has been achieved through these networks. Since their inception, 11 addenda have been published.Today, the OECD Guidelines comprise 90 adopted guidelines, 16 derestricted Guidance Documents and more than 30 draft guidelines and Guidance Documents. A list of these documents is available¹². In addition to the adopted and draft Test Guidelines as well as Guidance Documents, the Test Guidelines Programme produces documents and reports that are useful as background information (e.g. Detailed Review Papers and Workshop Reports).

The OECD comprises 30 Member States¹³. Agreement on the OECD Test Guidelines follows submission to the OECD Council. Here agreement is based on Consensus. Most but not all OECD Member States¹⁴ take part in the Test Guidelines programme.The Test Guidelines are incorporated into EU legislation by including them in Annex V to Directive 67/548/EEC¹⁵. As a consequence, the Guidelines have a mandatory position in the requirements for testing of chemicals.

It should be noted that there is an overlap in the scope of these test methods and a number of ISO and CEN standards. The latter have been developed in support of environmental legislation, rather as part of chemicals control legislation. There is a considerable overlap both in the scope and detailed content of many of these test methods. Since the purpose of the standards is mainly in support of environmental legislation, this overlap is most apparent in tests for environmental effects. However, a range of ISO¹⁶ test methods, particularly those applied to medical appliances, also have a considerable overlap with the OECD test methodology. A report listing the relevant OECD test guidelines and the corresponding ISO standards has been prepared by the OECD¹⁷.

4. Conclusion

The procedures in the three examples described above are in principle very similar to those resulting from the use of the New Approach. In all cases, detailed technical guidance in the form of standards, guidelines, or other relevant documents are elaborated by other organisations than working groups functioning directly under the European Commission. In all three cases, the recommendations or guidelines that have been developed as instruments that are not necessarily legally binding, are subsequently incorporated into legally binding EU legislation.

These working groups normally include representatives from all EU Member States. Ireland is not represented in the UN CETDG Transport Working Group; Luxembourg is not represented in the OECD Test Guidelines programme. The results of both programmes are subsequently incorporated into EU legislation, in practice with few if any amendments. However, as both countries are Member States, they are present when these guidelines are incorporated into EU legislation. A similar situation applies to the EEA Countries: Iceland does not take part in the UN CETDG Working Groups or the OECD Test Guidelines programme; Liechtenstein does not take part in the OECD Test Guidelines programme or the UN Codex Alimentarius Commission work. Since EEA Members are consulted on EU legislation (although they do not have voting rights in the adoption), these countries are consulted when these guidelines are adopted as EU legislation.

In all the three fora concerned, other interest groups including Industry, trade unions and other NGOs have the right to participate as Observers. In addition, adoption of these recommendations at a national level also includes consultation with a large range of government bodies and national organisations.The workings of these organisations have as a result not in general been criticised for a lack of broad consultation. In the case of the development of standards, concern has been expressed that consultation is insufficiently broadly based. The Council Resolution of 28th. October, 1999 on the role of standardisation in Europe¹⁸ point 39 stresses that "interested parties such as workers', consumers' and environmental interest groups should be fully involved in the standardisation process at all relevant stages when standards are drawn up at the international level". Both European consumer and environmental interest groups have expressed dissatisfaction with the process.

In all the three fora concerned, the votes are cast to reflect a national position, and not that of a private organisation. Hence, setting standards that have a direct consequence for human health, safety or the environment remain formally the responsibility of the government bodies concerned, and are not delegated to outside parties. The situation concerning standards is somewhat different. The actual standards are adopted in the context of the procedures of the relevant Standards Organisation.When approving standards mandated in the context of the New Approach, the Commission in the Official Journal publishes reference to them. A formal objection (safeguard clause) procedure can be introduced against a standard if a Member State or the Commission notes that a harmonised standard does not satisfy the requirements of the Directive. The Commission then decides after consultation with the Member States whether these objections are justified, and, if they are, reference to the standard is withdrawn in the Official Journal. However, the formal objection has no effect on the standard, but only on the presumption of conformity.

Finally, all three fora involve international partners outside the EU/EEA area. In the case of the UN CETDG and Codex Alimentarius, membership is in principle open to all UN Member States, although in practice, not all take an active part.The membership of the OECD is more limited. However, in many areas, the OECD cooperates closely with the United Nations Organisations with similar interests. In the area of chemicals' control, the OECD cooperates closely with a number of different UN organisations in the process of the harmonisation of classification criteria. The OECD has taken the lead in discussions of classification of criteria for human health and the environment, whilst the UN CETDG has taken the lead in discussions of classification for physical-chemical effects. Since in any case, the fora concerned provide non-binding recommendations, the final inclusion of these as EU legislation continues to be a matter for the European Community, irrespective of the wider scope of the organisations in which the recommendations are developed. In all three cases, development of standards in these fora has the character of international rather than regional co-operation, and, as such, is closer to the level of discussion at ISO than in CEN.

Experience in these fora shows that a number of different organisations are currently used to develop technical guidance similar to that developed in Standardisation organisations such as CEN and ISO. It should be noted however, that all three examples relate to developments of standards for specific areas, rather than the more general scope of the wider range of CEN / ISO product related standards.The Governmental basis of these organisations makes it possible to avoid some of the difficulties.

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