12 SAFEGUARD CLAUSE AND PROCEDURE - ATEX 94/9/EC guidelines 4th edition

12 SAFEGUARD CLAUSE⁵² AND PROCEDURE

The safeguard clause referred to in Article 7 of the Directive is the EU procedure whereby any measure taken by a Member State, on the grounds of non-compliance with the Essential Health and Safety Requirements and where it is deemed that equipment is liable to endanger persons, animals or property for the purpose of withdrawing from the market, prohibiting the placing on the market or restricting the free movement of equipment accompanied by one of the means of attestation provided for in the Directive and therefore bearing the CE marking, must be immediately notified to the Commission by the Member State which has taken it.

In considering whether the safeguard clause should be triggered, Member States and the respective enforcement authorities will need to consider whether the non-compliance is substantial or can be considered a non-substantial non-compliance to be resolved without recourse to the procedures enabled via the safeguard mechanism.

For example, a non-substantial non-compliance could consist of illegibility of the CE marking. In such cases, the Member State could issue a compliance notice to the manufacturer or authorised representative or take other actions allowed by national legislation to encourage the responsible person(s) to take appropriate corrective action.

Member States will need to consider in each case whether the non-compliance is liable to endanger persons, animals or property and if the safeguard clause is the most effective means of ensuring the safety of persons, animals or property, which remains paramount under this section of the Directive.

Any notification, which fulfils the criteria of invoking the safeguard clause, is followed by a process of consultation between the Commission and the "parties concerned". The "parties concerned" primarily means all Member States of the EU, the manufacturer or his authorised representative established within the EU or, failing them, the person who placed the product on the EU market.

The consultation procedure enables the Commission, on the basis of the above reasons, to assess whether the restrictive measure is justified. This means that the measures notified to the Commission must be accompanied by detailed information specifying in particular the reasons why the Essential Health and Safety Requirements laid down in the Directive have not been complied with by the product concerned.

Where the Commission finds, following such consultation, that the measures are justified, it immediately informs the Member State which took the initiative and the other Member States. In the Commission's view, the objective of informing the other Member States is to prompt these Member States to take appropriate measures in accordance with Article 3 of the Directive.

Where the Commission finds that the measures, adopted by the Member State are not justified, it will ask that Member State to withdraw its measures and immediately to take the appropriate action to re-establish the free movement of the products in question on its territory. If a Member State refuses to follow the Commission's position the Commission reserves the right to proceed under Article 226 of the EC Treaty.⁵³

In order to ensure transparency and the proper uniform application of the safeguard clause, Article 7.4 states that "the Commission shall ensure that the Member States are kept informed of the progress and outcome of this procedure".

In addition to this provision the Directive foresees in Article 6 (1) a specific Standards Safeguard Clause. Where a Member State or the Commission considers that a harmonised standard does not fully meet the Essential Health and Safety Requirements of the Directive they shall bring the matter before a special Committee set up under Directive 98/34/EC​⁵⁴. The Committee shall examine the case and deliver an opinion to the Commission. In the light of this opinion the Commission shall inform Member States whether or not it is necessary to withdraw the references to those standards from the published information.

⁵² For a detailed analysis of the "Safeguard clause", see the "Guide to implementation of the Community harmonisation Directives based on the New Approach and the Global Approach", sheet I/E, Chapters 2, 3, 4. 

⁵³ Article 226 of the EC Treaty: if the Commission considers that a Member State has failed to fulfil an obligation under this Treaty, it shall deliver a reasoned opinion on the matter after giving the State concerned the opportunity to submit its observations. If the State concerned does not comply with the opinion within the period laid down by the Commission, the latter may bring the matter before the Court of Justice.

⁵⁴ Directive 98/34/EC of the European Parliament and the Council laying down a procedure for the provision of information in the field of technical standards and regulations; OJ L 204, 21.7.1998, p. 37, as amended by Directive 98/48/EC.