Overview
The European Union has harmonised product standards across numerous areas in order to facilitate free movement of goods throughout the EU. Numerous Directives have been made at EU level which has become law in Ireland setting out the minimum of standards for products and goods over the last 35 years. The advantage of these common standards is that once goods comply with the standards in Ireland, an exporter can know that they comply automatically with standards throughout the EU.
Under the newer approach, EU Directives seek to harmonise the essential health and safety requirements of goods without prescribing detailed technical requirements in the law itself. European Standards Bodies prepare and publish technical standards in support of the Directives known as harmonised standards in order to meet the essential health and safety requirements. Most harmonised standards have evolved through industry groups and are not intended to be restrictive or prescriptive.
The Directive states the legal objectives (i.e. the minimum essential health and safety requirements) (HSR) and harmonised standards produced by the Standard Bodies identify the technical means to meet these objectives. Harmonised standards are one method of reaching the HSR but are not mandatory. Compliance gives a presumption of conformity with the required HSR.
There are harmonised standards across a vast range of products. They include, for example, motor vehicle, agricultural vehicles, construction, equipment and product. It covers electrical products, machinery, foodstuffs, ceramics, cosmetics, dangerous substances, equipment, pharmaceutical products, petroleum products.
CE Marking must be applied to the certain products to verify compliance with the essential requirements under the relevant Directives by manufacturers and importers in order to market them in the EU or EFTA. In order to procure CE marking, it is necessary to verify which EU Regulations apply to the product. Conformity assessment procedures could involve self-declaration, testing, inspection or quality system approval. However, they will create a presumption of conformity.
Products must comply with the essential requirements of the Directives. It is necessary to identify whether an independent assessment of conformity is needed from a notified body. This will depend on the product. CE marking must not be affixed until all necessary certifications have been obtained from the notified bodies. Compliance maybe through a national standards body.
A declaration of conformity and the required supporting evidence must be available to the relevant authority in the member state upon request. Technical documentation required by the Directive must be maintained.
In areas where EU law requires manufacturers to affix the CE mark before marketing suppliers must submit to conformity assessment procedures performed by a standards body. The NSAI is the standards body for Ireland.
In order to be entitled to affix the CE mark, the applicant must comply with the conditions relevant to the goods concerned. Certain fees are payable to the national standards body. There may be conformity assessment procedure or quality control system.
The certificate holder entitled to provide the CE mark must communicate changes to the standards body. Certain adverse incidents must be notified to the standards body. Records must be maintained.
Modern Regulation
In 2008 the EU adopted a Regulation which has direct effect throughout the EU in order to remove the remaining obstacles to free the circulation of products. The regulation sets out the requirements for EU wide accreditation and marketing of products. The regulation was also designed to improve safety standards for products and imports. They enhance conformity and quality assessment of products and reinforce rules and requirements on notification to conformity assessment bodies. They increased use of accreditation and enhanced the “CE” marking.
The Regulation establishes a common legal framework for industrial products. It strengthens the free common market in products which are not yet subject to EU harmonisation such as certain foodstuffs, furniture, bicycles, ladders, precious metals.
Under the Regulation, the objective is to ensure that denial of mutual recognition of each member state’s standards becomes the exception by putting the onus on member states to objectively justify why they propose to deny recognition of another member state’s standards.
The EU has gone very far to make it very difficult to deny real effect to the Treaty rights to provide goods and services by making it very difficult for member states to justify failure to recognise. The onus is on the member state to respond to the foreign business and to justify the failure to recognise the national standard. It must do so within a short time frame. The purpose of these recent Regulations is to ensure member states do not use the very limited base for denying mutual recognition in a way that is unfair to businesses.
If a member state proposes to deny mutual recognition, it must give written notice to the business specifying the technical rule, setting out technical and scientific evidence proving that the proposed decision is justified by an overriding reason of public interest and that no less restrictive measure can be taken. The decision must be based on the characteristics of the product. The business may submit comments to the member state within time limits. The member state must assess the comments before a decision is made. In giving a decision it must provide technical and scientific justification for the decision based on the limited grounds in the European Union Treaties.
Each member state must designate at least one Product Contact Centre and inform European Commission and other member states. This could be a new or existing public body. Various tasks must be performed free of charge by the member state within 15 days.
These tasks include the following;-
- providing the technical information applicable to a specific type of product in that state
- advise whether the marketing and sale product is subject to prior authorisation
- give contact details of the relevant regulatory authorities
- describe the remedies available in the event of a dispute between the authorities.
