(ANEC is indebted to BEUC for its agreement to use an internal note as the basis for this briefing note)

On 14th February 2007, the Commission adopted three proposals on the New Approach, constituting together “the new Internal Market Package for Goods.”

The Commission’s proposal may affect current and future regulations on food, food labelling, product safety, product labelling, environmental product standards and potentially most new product laws (toys, cosmetics, household products, electrical/electronic products, clothes, textiles etc).

The New Approach is a policy adopted in 1985 under which European directives or other measures only set essential requirements for products in terms of safety, health and other characteristics. Manufacturers of products covered by a New Approach directive must ensure that their products meet the relevant essential requirements. As a sign that this is the case they must apply CE Marking on the product or accompanying label. CE Marking is thus a claim by the manufacturer that the product meets all the essential requirements of the relevant directive. About 15% of products on the European market are covered by one or more New Approach directives. These are products in areas which did not benefit from mutual recognition and free circulation in the European market due to Member States raising frequent health and safety considerations at national level.

To support the essential requirements, the Commission asks (‘mandates’) the European standards bodies to develop harmonised standards. Manufacturers do not have to follow these harmonised standards but if they do, they will benefit from a presumption that their products comply with the essential requirements.

Manufacturers who choose not to use harmonised standard(s) have to prove in another way that products comply with essential requirements.

Manufacturers are required to retain technical document supporting their claim and are also subject to a conformity assessment under which their product or manufacturing processes may be checked by "notified bodies". The extent of the conformity assessment system varies from one product area to another. In some cases, where the manufacturer follows the harmonised standard(s), conformity assessment consists simply of a self-declaration by the manufacturer. In other cases, and especially when the manufacturer does not follow the harmonised standard(s), a notified body has to certify the products or manufacturing process - there are fifteen or so different modules or models of conformity assessment procedures, each relevant to a particular type of product or products.

CE Marking is a claim by the manufacturer that the product complies with the essential requirements. It is not necessarily a claim that the product or process has been assessed or examined or certified by a notified body or any other third party - because this is not required in all cases. CE Marking also applies equally to European and imported products covered by the New Approach - so it is not an indication of origin, even if many people think it is.

The main areas of consumer products covered by the New Approach are ‘low-voltage’ (under 1000V for AC) electrical appliances and toys.

Established in support of the General Product Safety Directive (GPSD), RAPEX applies to all products intended for consumers which, used under normal or reasonably foreseeable conditions, present an immediate and serious risk to the health and safety of consumers. It covers both foodstuffs and industrial (non-food) products. RAPEX is also applicable to consumer products covered by the New Approach directives and it is, in particular, important for toys and low voltage products. This is because the New Approach directives do not provide for such a procedure but instead a less-immediate action according to a ‘Safeguard Clause’ set out in the New Approach directive.

The three proposals adopted on 14th February are:

1 A proposal for a regulation on Accreditation and Market Surveillance

2 A proposal for a Decision on a common framework for marketing of products

3 A proposal for a Regulation on the application of national technical rules

The accreditation proposal contains some good provisions for strengthening the current conformity assessment procedures (accreditation/notified bodies) in the member states. Each member state will have to establish one distinct national accreditation body funded from the EU budget. The main function of the accreditation bodies is to accredit the notified bodies, i.e. to make sure that the notified bodies meet the relevant technical and other requirements. The Commission clearly believes that accreditation bodies funded directly from the EU budget will be more effective.

The accreditation proposal also includes requirements on member states to perform market surveillance to ensure that products covered by the New Approach do meet the essential requirements. This is good in principle but the relevant articles are vague and it is not clear if they require actual inspection of products after they have been put on the market (post-marketing surveillance).

The accreditation proposal does not seem to apply to most laws regarding the health and safety of food. However, it may:

Extend the conformity assessment system to food laws other than health and safety - labelling laws for example?

• Extend the conformity assessment system to the task of enforcing or checking compliance with the laws on organic food, food with special characteristics and geographical indications.
• Extend the conformity assessment system to enforcing or checking or ensuring compliance with all other laws - environmental rules for example.

In other words, the scope of the proposal is not well-defined.

The proposal for a Decision asks Parliament and Council to agree in principle to use the New Approach when making future laws that define requirements for products. Detailed specifications may still be made if necessary but the bias will be to laws setting out essential requirements.

The proposal for a Decision also includes very detailed provisions on obligations of manufacturers, the accreditation and conformity assessment system and CE Marking. It includes fifteen different modules or models of conformity assessment procedures. The idea is that future New Approach directives laws will closely follow the text of the decision, and choosing one or more of the fifteen models of conformity assessment as appropriate for the product or sector in question. In other words, it is a detailed template for all future product laws.

Food safety laws and laws on medicines (among others) are excluded from the Decision but we believe the Decision will apply to future laws relating to food labelling, cosmetics, environment and many other areas. In principle, future laws in these areas should be New Approach style. The possibility is left to lay down detailed specifications if necessary but in practice the Decision may make it more difficult to argue for detailed specifications in future laws.

Another effect of the decision will be to extend the use of CE Marking.

Although the proposal omits products falling under the GPSD from its scope, we detect that some MEPs would like to see the GPSD absorbed in order to avoid having two systems in operation in parallel. However, as the proposal sets out a moratorium or cooling-off period for claims made under the ‘revised’ New Approach, clearly some derogation would need to be given to consumer products if safety of the consumer is not to be prejudiced.

The intention of the proposal on national technical rules is to strengthen mutual recognition and to make it more difficult for member states to use national rules to block a product legally on sale in another member state.

Briefly, a member state wishing to block or require the withdrawal of a product because it is in breach of national rules will have to inform the manufacturer or importer and give them twenty working days to comment on the action proposed. The manufacturer or importer must also have the right of appeal against any ban or restriction to the national courts.

The proposal on technical rules also requires each member state to set up Product Contact Points to help economic operators whose products may have problems under national rules.

The proposal does not apply to withdrawals under the General Product Safety Directive or food safety laws, but appears to apply to other national restrictions such as labelling/marking requirements, environmental standards, conditions of use/disposal etc, for food and non-food products. In these cases the procedure laid down in the proposal must be followed.

The explanatory material from the Commission says that the burden of proof is placed on the national authority wishing to apply a national rule that restricts access to the national market. The Commission also says that this is a change to the current situation of “legal uncertainty” regarding the burden of proof in cases of dispute. At one point the Commission says that it is for the member state “to prove that a product is unsafe” before they can deny it access to the market.

It is not clear that the proposal has the actual effect the Commission claims for it. It certainly imposes a twenty day procedure, but it does not explicitly mention burden of proof except perhaps in recital 14. Even if the regulation does reverse the burden of proof, it is not clear whether this is actually a change in the current law – although it may at least be a clarification.

Certainly, the proposed regulation on technical rules will make it more difficult to apply national rules to deny access to the market. There may be many national rules that should not be used in this way but again little is known about the overall scope or “reach” of the proposal.

13 June 2007