Framework for product safety

The Product Safety Act came into force on March 1, 2001, repealing the Quality Control (Exports, Imports and Local Goods) Act, Cap 225 of 1971.

It implements Directive 2001/95/EC of the European Parliament and of the Council of December 3, 2001 (ex 92/59/EEC of June 29, 1992) popularly referred to as the General Product Safety Directive.

This measure forms part of the EU Acquis Chapter 23 that deals with consumer protection and seeks to establish a common framework for ensuring the safety of products sold or offered for use by consumers.

It achieves this by specifying that products supplied to consumers, whether for a consideration or provided free of charge, must be safe; defining a safe product; and laying down a framework for assessing safety.

Article 38 of Part V of this Act is the enabling part that provides for the minister responsible for consumer affairs to make regulations, on the advice of the Malta Standards Authority on, inter alia, the design, methods of manufacture, construction, safety and environmental impact of any class, category or type of goods, materials, substances, plant, installations or structures.

The MSA has already been involved in the issue of a significant number of such regulations. The full list may be consulted on the MSA Website (www.msa.org.mt)

Construction Products Regulations

By virtue of the Product Safety Act, Cap 427, the Construction Products Regulations, transposing fully the Construction Products Directive (CPD) - CPD - (89/106/EEC) were published in the Government Gazette No. 17,157 of November 2, 2001, as Legal Notice 270 of 2001.

These regulations came into effect as from July 1, 2002, simultaneously repealing the following old mandatory orders that used to regulate specific fields of construction in Malta.

The CPD aims to break down technical barriers to trade in construction products between member states in the European Economic Area (EEA). To achieve this the CPD provides for four main elements:

¤ a system of harmonised technical specifications;

¤ an agreed system of attestation of conformity for each product family;

¤ a framework of notified bodies;

¤ the CE marking of products.

Harmonised technical specifications

Technical specifications are harmonised European product standards (hENs) produced by CEN/CENELEC or European Technical Approvals (ETAs) produced by the European Organisation for Technical Approvals (EOTA).

Technical specification for a product covers all the performance characteristics required by regulations in any member state.

In this way manufacturers can be sure that the methods of test and methods of declaration of results will be the same for any member state, (although the values chosen by regulators may be different from one member state to another).

The parts of the standard that are not required by regulations are termed the voluntary or non-harmonised parts of the standard.

Conformity for each product family

The attestation system is the term applied to the degree of involvement of third parties in assessing the conformity of the product according to the relevant technical specification(s).

A significant barrier to trade currently arises from the different attestation levels required by member states for the same product. Hence these requirements are also 'harmonised' under the directive.

For each product family, the attestation system has been decided collectively by the member states and the Commission on the basis of the implications for health and safety of the product, and on the particular nature and production process for the product itself.

Once a manufacturer has had all the appropriate attestation tasks carried out for his product he is required to complete a Declaration of Conformity that is kept with his technical file concerning the product.

This may be supported by a certificate of product conformity, fpc certificate, test laboratory reports or certificates, and/or own test results, depending on the attestation system required.

Framework of notified bodies

Notified attestation bodies are the product conformity certification bodies, FPC certification bodies, inspection bodies (in some countries) and test laboratories that are competent to carry out the attestation tasks described in the previous section.

Such bodies are first approved by their respective member states to carry out certain designated tasks, and then notified to the Commission and other member states.

Hence they are variously called 'approved bodies', 'designated bodies', or 'notified bodies' or sometimes 'Article 18 bodies' after the relevant clause in the directive.

Maltese bodies can be fully notified by the MSA against a finalised technical specification, or somewhat in advance provided they are already working in a closely similar area (for example to an MSA, BS or draft hEN for the same product).

CE marking

CE marking is a 'passport' enabling a product to be legally placed on the market in any member state. However this does not necessarily mean that the product will be suitable for all end uses in all member states.

The CE marking is not a quality mark. It simply shows that the product addresses the regulatory requirements. Quality marks are allowed to appear alongside the CE marking, provided their purpose cannot be confused.

In Malta, reference to the acceptability of products with CE marking is already included in general terms in our Building Regulations.

Summary of implications

From April 2001, the visibility of CE marking on construction products will begin to accelerate. In all, there will be over 600 product standards in support of the CPD, the majority of which will be available by 2006.

Manufacturers and their trade associations will need to be aware of progress on the technical specifications that apply to their products and will need to familiarise themselves with the technical content.

For standards, the basis for CE marking is set out in Annex Z or for ETAGs in Chapter 8. If the attestation system requires involvement of a certification or test body, the manufacturer will need to commission a notified body to carry out the work.

CE marking will be essential if manufacturers wish to export to countries in which CE marking is compulsory. Manufacturers who wish to export will need to determine, for the country of destination, the performance values required by the regulations of that country for the chosen intended use.

Enforcement Authorities (Consumer and Competition Division Inspectors, Building Construction Industry Department, Market Surveillance Directorate, etc.) will need to be aware of the significance of CE marking and the provisions of the Maltese implementing regulations namely the Construction Products Regulations 2001, and architects, engineers, building control bodies, specifiers, and other practitioners will need to keep abreast of the introduction of product standards and ETAs, and amendments to building regulations and their supporting documents.

Potential Maltese attestation bodies will need to check progress on standards and ETAGs with a view to provisional notification for those whose introduction is some way off or full notification for those whose introduction is imminent.

Membership of the MSA standards users' group will assist in this process. MSA guidance gives the criteria and procedures for notification. In advance of the introduction of standards/ETAGs attestation bodies may wish to establish links with relevant manufacturers.

This topic shall be discussed in further detail during a one-day conference being organised by the Malta Standards Authority. For more information visit www.msa.org.mt.

Ing. Anthony Camilleri, B.Mech.Eng. (Hons), is head of the Consumer and Industrial Goods Directorate of the Malta Standards Authority