Presumption of conformity is a legal concept surrounding Harmonised Standards that denotes the relationship between the legislative and standardization processes. The European Commission and the European Standardisation Bodies (CEN, CENELEC, ETSI,) collaborate to produce Harmonised Standards. The contract (or mandate) from the EU Commission to these bodies stipulates that they are requested to produce a standard that will provide a technical solution, or a technical interpretation, of an essential health and safety requirement.
"standardised test methods and specifications shall in addition be reliable and credible for technical experts such as OHS experts, consumers associations and testing laboratories"
When the standard is completed and the conditions of the Commission’s mandate are met, the Commission publishes the notice of its completion in the Official Journal of the European Communities. Once the notice is published, the standard takes on the presumption of conformity mantle. A manufacturer, therefore, using a Harmonised Standard in the design and/or production of the product, is presumed to be in conformity with the essential requirements of the law.
The presumption of conformity is granted to a product in conformity with an EN harmonised standard only for the essential requirements actually covered by this standard. If the existing European harmonised standards do not cover all applicable EHSRs they have indeed, in addition to the application of these standards, to assess the conformity to the EHSRs not covered by using other relevant technical specifications and test methods. This could lead to disparities in judgement of the conformity of PPE and to litigations.
Importance of technically robust standards
On a technical point of view, standardised test methods and specifications shall in addition be reliable and credible for technical experts such as OHS experts, consumers associations and testing laboratories. They shall in particular correspond to the highest level of safety and ergonomics that - according to the current state of the art - can reasonably be expected from PPE. They shall also assess the real comfort and protective performances of the PPE and give reproducible, repeatable results.
There is still some work to do for the improvement of the existing EN standards on PPE (harmonisation of test methods related to the same characteristic common to several CEN Technical Committees or to sectors to reduce the unnecessary costs, harmonisation /clarification of markings, improvement of representativeness, reproducibility, repeatability of the test methods, consideration of uncertainty of measurement questions...).
In practice, EN harmonised standards have today gained a good reputation that goes far beyond EU frontiers owing especially to growing globalisation of commercial relations and internationalsation of companies in this sector. The need for international standards was nevertheless recognised by all economic and social entities.
For the transfer to ISO of the existing European standards the question was: What strategy should be adopted to conciliate legitimate preservation of normative assets, European manufacturing interests and the economic necessity for companies to open themselves to the world? Should one rush into the nascent ISO movement to take control of it, whilst the need is not yet vital, or would it be wiser to “make haste slowly” by waiting a little longer for the CEN standards to extend their reputation and be ready to react quickly when the need makes itself felt?
In the field of eye protection, the global tendency is not to make haste. In my opinion, there are two main reasons which can explain this situation:
The existing ISO standards were drawn up in the seventies, essentially by European experts and are the basis of the EN standards developed later by CEN/TC 85 which are widely used in the world
The weariness of the experts involved in many European and international committees and working groups and the costs of the corresponding participation
The global importance of good information for users
Improving the quality of information increases consumer’s ability to make a reasoned choice at the point of sale. This helps to minimise risk of incorrect or inappropriate purchases. Consumer uncertainties are reduced and consumer satisfaction is increased. Those who supply a high quality of consumer information enhance their commercial reputation, and save time and money by reducing enquiries and complaints.
When wearing PPE, the consumers, believing to be overprotected, are often tempted to take abnormal risks. And as you know, using wrong protective eyewear sunglasses or poor quality sunglasses may actually increase the amount of damage the sun does to your eyes. This shows how important the proper information is to the users about the limits of protection given by the PPE.
Product information and communication has to be considered as one of the fundamental elements of any product and as such it has to be clear, uncomplicated and designed to minimise the chances of consumer confusion. It should be taken into account that this Information supplied by the manufacturer may only be considered as effective, when it is perceived, understood, retained and appropriately applied. This is of particular importance for mass-market products.
Instructions for use
On a technical point of view, the main aim of the “Information to be supplied by manufacturer” is to enlighten the consumers/workers on the PPE by supplying “Information to enable them to assemble, install, operate, store, maintain, repair, and dispose of the product.”
This information must consider the whole life cycle of the product (use, maintenance, repair and disposal).
On a legal point of view, this information is also of great importance, for purchasers, users, employers, manufacturers, notified bodies and market surveillance authorities.
This document which shall accompany all PPE putted on the EU market shall be established in conformity with the Health and safety requirement 1.4.of the PPE Directive 89/686/EC and when applicable with the other specific requirements of this directive.
"the main benefits of the New Approach are a high level of protection as well as the free circulation within the EU of a large number of products"
The respect of the information given in the “Instruction for use” by the purchaser/user is in principle a contractual obligation, provided this information is clear and precise enough. In this way, the instruction for use has a legal importance by defining to a certain extent, the limits of responsibilities between manufacturers and purchasers/end-users in the correct use of PPE.
Training of manufacturers, distributors and retailers
For several years, information and training courses intended for the manufacturers, distributors and retailers of PPE have been held in various European EFTA and EU countries 7 . They are organised either on the initiative of the national authorities or to that of the trade unions of manufacturers and retailers and aim not only to one better knowledge of the European lawful system but also at a better appropriation of the prevention of the accidents and diseases concepts. Certificate or diplomas are generally awarded to trainees who pass successfully the evaluation tests.
It could be worthwhile to harmonise this “Training of the sales forces approach” on a high level basis as it is organised in Finland, to extend this concept in all EU countries and to adapt it to department and hardware stores sales persons. It could be interesting for ESA to launch similar training campaigns for protective eyewear distributors and retailers.
The revision of the new approach
The main benefits of the New Approach are a high level of protection as well as the free circulation within the EU of a large number of products. This regulatory approach has considerable international impact. Many non EU countries having adopted similar approaches (Russia, Japan, China, developing countries...).
However one can recognise that the New Approach does not always assure a sufficient, perceptible level of confidence in the CE marked products manufactured in the EU or imported from third countries. Consumers do not always feel that they are effectively and correctly protected.
The revision of the New Approach launched several years ago was not to add new layers of requirements but to ensure better and more equal functioning of what already exists in particular in order to reinforce the credibility of the CE marking and to bring coherence to the overall system.
The draft two documents of the EU Commission were definitively adopted at the plenary session of the EU parliament ( http://ec.europa.eu/enterprise/newapproach/review_en.htm ):
A new regulation which put in particular forward reinforced Community policies on market surveillance (obligations of Member States, type of checks and controls, safeguard mechanisms...) and accreditation (mode of operation, cross- frontier accreditation, peer evaluation). The aim is to ensure that products respect a high level of protection of public interests such as health and safety in general, of health and safety at the workplace, protection of consumers, of the environment, and of security. 8
A Decision, a sort of tool box, setting out the common framework of general principles and reference provisions for the revision or recast of existing directives such as PPE Directive 89/686/EEC. It contains rules related to conformity assessment procedures, EC declaration of conformity, obligations of economic operators, CE marking, safeguard procedures. 9
The improvement of the rules of the new approach and in particular the strengthening of the market surveillance policy will reinforce the responsibilities of all sectors and will require them complementary efforts to rigour. As a matter of fact, the intensification of controls and the rigour by which national authorities will prosecute cases of non compliant or unsafe products will encourage market actors and notified bodies to watch over the unimpeachable character of their practices and of the effective safety and compliance of the CE marked PPE.
The entry in force of the social directive on exposure to artificial optical radiations
The European social directives are not related to the design and free circulation of the products. They are aimed specifically at encouraging the improvement of the safety and health of the workers at their workplace and prescribe only minimum requirements. Contrary to the “New Approach” directives, Member States remain free to keep or to adopt more stringent national measures. However national measures must not have the effect of introducing requirements going beyond those of the Single Market directives for products.
The only link between the two PPE directives rest on the fact that according to the directive 89/656/EEC on the use by workers of PPE at the workplace 2 , the employer shall provide to workers PPE which comply the directive 89/686/EEC on the design of PPE. The employer shall also make sure in particular that PPE be appropriate for the risks involved, without itself leading to any increased risk, takes account of ergonomic requirements, compatible with the use of other PPE. After having carried out a suitable analysis of the risks, the only real possibility for the employer to be able to select an appropriate PPE satisfying the provisions of this directive is to rely on the quality of the CE certified PPE available on the market, on the information given by manufacturers and on that account to rely on the quality of the reference standards and of the practices of the notified bodies involved in the CE certification process.
The directive 2006/25/EC on optical radiation recently adopted10 set out in particular obligations for employers and exposure limit values in the field of UV, IR and visible light. The reference values used in CEN standards as a reference for the evaluation of the performances and the definition of protection classes of optical filters should in particular be in coherence with the limit values fixed in this social directive. These aspects are under checking by the CEN/ TC 85 on Eye and Face protection in particular for standards on optical filters (EN 169, 170, 171, 369, 207, 208, and 12254) and on sunglasses for industrial use (EN 172).
Until now, the main efforts of the stakeholders of the PPE sector have been devoted to the technical quality of the products to be put on the EU market and of the corresponding EN standards. These efforts must continue, much progress being desirable and possible in this field for the benefit not only of consumers but also of manufacturers. The soon reinforcement of the market surveillance in the EU is one more reason to continue to put effort in this way.
If having safe, reliable and comfortable PPE is of very high importance, we should not forget that the sensitising and information of purchasers, end-users and consumers on products especially on their correct use, maintenance is one other essential route for the prevention of occupational but also of non occupational injuries and accidents.
To achieve this difficult goal, none of the possible ways of action of whatever legal, normative, educative or informative character, must be neglected. All interested parties at European and National levels should consider more carefully the social and economical benefits of good information of end-users and purchasers of PPE.
Published: 10th Jul 2009 in Health and Safety International