Standards

The International Standards Organization, ISO, has developed product safety standards similar to those at CEN.  Standard numbers under the ISO and EN systems use a common numeric system.  This facilitates international trade.CEN has developed standards in parallel with the other international bodies. 

CENELEC is a European regional standards organization that together with its sister organizations CEN, the European Committee for Standardization, and ETSI, the European Telecommunications Standards Institute, compose the so-called and known European Standards Organizations (ESOs) that are officially recognised by the European Commission and act as a European platform through which European Standards are developed.

There are national, international and EU standards.  The National Standards Authority of Ireland draws up Irish standards  There have been many thousands of Irish standards.  The British Standard Institute is the British equivalent of the NSAI. 

EU Standards

In the European Union, only standards developed by CEN, CENELEC, and ETSI are recognised as ‘European Standards’. Hence, CENELEC closely cooperates with CEN and ETSI; working jointly in the interest of European harmonization, creating both standards requested by the market and harmonized standards in support of European legislation.

CEN, CENELEC, ETSI are the regional mirror bodies to their international counterparts, i.e. ISO (the International Organization for Standardization), IEC (the International Electrotechnical Commission) and ITU-T (the International Telecommunication Union, telecommunication standardization sector) respectively.

In the absence of EN Standards, European Norms, Irish standards apply. In the absence of an Irish and EN standards, British standards are commonly recognized as persuasive.

EU Directives

Under the more modern post-1985 approach, European directives have provided for the essential health and safety requirements of goods and products.  The essential safety, health requirements are set out in EU law and converted into Irish law.  These are usually backed up by more detailed technical standards, European norms are approved by European standards bodies developed by CEN, CENELEC.

Under the post-1985 approach, manufacturers can indicate compliance in most cases by placing the CE mark, by way of self-certification.  The requisite procedures to permit the affixing of the mark vary from product to product.

The requirement for common standards applies in the harmonised fields.  EU states may not impose more or less restrictive requirements and standards than provided in Directives. It is desirable in the interests of the single market to have harmonised standards of consumer protection across the EU. 

Outside of the harmonised field, states may apply further and higher standards. Financial services and immovable property, for example, are subject to minimum standards, but individual EU states may provide higher standards. 

European Harmonisation I

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 have become law in Ireland setting out 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.

Most harmonised standards have evolved through industry groups. The standards are not intended to be restrictive or prescriptive. 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.

The 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 for the products.

European Harmonisation II

The Directive for the relevant product type typically states that legal objectives (i.e. the minimum essential health and safety requirements) (HSR). The 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 necessarily the only way to do so.  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. They also cover electrical products, machinery, food stuffs, ceramics, cosmetics, dangerous substances, equipment, pharmaceutical products and petroleum products.

CE Marking I

CE marking must be applied by manufacturers and importers to many products to verify compliance with the essential requirements under the relevant product standards 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.

The manner of conformity verification differs between various types of product.  Conformity assessment procedures could involve self declaration, testing, inspection or quality system approval.  However, they will create a presumption of conformity.

It may be necessary that an independent assessment of conformity is issued by a  standards body.  This will depend on the product.  CE marking must not be affixed, until all necessary certifications have been obtained from the standards body.   Compliance may be through a national standards body. The National Standards Authority of Ireland is the notified standards body for Ireland.

CE Marking II

In areas where EU law requires the manufacturer to affix the CE mark before marketing, suppliers must submit to conformity assessment procedures performed by the standards body.  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. 

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.

The certificate holder entitled to provide the CE mark must communicate changes to the product to the standards body. Certain adverse incidents must be notified to the standards body. Records must be maintained.

General Products Regulation

The National Consumer Agency, now the Competition and Consumer Protection Commission deals with product safety.  The Commission can take legal and administrative action to enforce the legislation. 

In 2008 the EU adapted 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 rules were also designed to tackle unsafe products and  third party imports.  They enhance conformity and quality assessment of products and reinforce rules and requirements on notification to conformity assessment bodies.  It increases use of accreditation.  It enhances 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 food stuffs, furniture, bicycles, ladders, precious metals.

Measures to Ensure Effective Common 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 Regulation’s  objective is to ensure that denial of  recognition of one EU state’s standards becomes the exception. It does this by putting the onus on the authorities in the member state of import to objectively justify why it purports to deny recognition of another member state’s standards.   .

The member state must respond promptly to the exporting business and to justify the failure to recognise the product standard.  It must do so within a short time frame. The purpose is to ensure that member states do not use the very limited bases for denying  recognition in a way that is unfair to businesses.

If a member state proposes to deny  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 exporter’s 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.

Designated Contact Centre

Each member state must designate at least one Product Contact Centre and inform European Commission and other member states.  This may 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 with the authority.

Sample of Specifc Regulation; Machinery

European standards are divided into three categories.  In relation to machinery, Category A covers standards applicable to all machines such as the design matters and risks.  Type B covers the protective,  safety and ergonomic aspects of machinery B1 and standards of safety components and device.  Type C standard covers specific types and groups of machines. Multiple standard types may apply to the manufacturer, based on the nature of the goods and the components.

New standards must be notified to the European Union by state.  The EU Commission may then evaluate their content with a view to reducing the risk that they become an obstacle to trade.  Standards, for this purpose, include those relating to the characteristics of the product, its levels of performance, safety dimensions, names under which it is sold, testing symbols et cetera. 

Machinery must comply with the essential health and safety requirements in the EU directives.  A technical file must be kept.  Certain types must submit to the National Standards Authority for type examination and approval.  There is then a declaration of conformity for the machine which should be issued.  CE marking is affixed.  The more dangerous type of machinery must be type examined.