A guide into stress-free product compliance

What is harmonised legislation?

Disclaimer: This document provides guidance and is not a legally binding interpretation and shall therefore not be relied upon as legal advice.

The scope of product legislation can be general ('any product which is intended for consumers or likely, under reasonably foreseeable conditions, to be used by consumers even if not intended for them') and specific ('shall apply to electrical equipment designed for use with a voltage rating of between 50 and 1 000 V for alter­nating current and between 75 and 1 500 V for direct current'). 

In addition, product legislation may set general requirements for products falling within its scope, as well as specific requirements. This can range from 'products may be placed on the market only if they are safe' to 'specific requirements for putting radio equipment into service'. 

The product legislation thus defines the requirements that a product must meet. In a technical file you collect the documents and certificates that prove that the requirements of the product legislation have been met.

Use of standards

To comply with product legislation (the term used is “to conform with") you can use standards. Standards can be used when all the risks of a product have been identified, so that after a risk assessment you know which essential (or other) requirements apply. Then you evaluate the standard and see if it covers the identified risks. 

Application of standards is voluntary. Applying a standard is 'a possible technical way to meet the requirements of product legislation'. The principle is always that an economic operator is responsible for the product. The use of standards remains the responsibility of the economic operator concerned. However, the use of standards is highly recommended, because standards are drawn up by experts in the relevant fields and you therefore do not have to 'reinvent the wheel'. Standards can therefore save you a lot of time, money and effort.For this reason, standards are seen as mandatory.  Deviating from available standards can even raise questions: "is there a good reason to ignore the available standards?

Different types of standards?

There are different 'types' of standards. In the EU there are three so-called 'standardisation organisations': CEN, CENELEC and ETSI. These organisations have committees with experts from different product groups that draw up standards. This may be on their own initiative, because there is a need for a standard, or it may be at the request of the European Commission (EC). 
 
At the request of the EC
When a standard is drawn up at the request of the EC, it can be harmonised. Harmonised standards are standards drawn up at the request of the EC. In addition, the EC considers that the level of the standard is sufficient to demonstrate that its application satisfies the requirements of product legislation. After approval by the EC, the standard is published in the Official Journal of the European Union (OJEU). We then speak of a harmonised standard. The advantage of harmonised standards is that they provide a 'presumption of conformity'. 
 

Presumption of conformity

What does a presumption of conformity mean? A standard is drawn up with a regard to a certain category of products or a certain risk.

When a standard does not cover a product in its entirety, there is no presumption of conformity for the part that the standard does not cover. The economic operator has then to find other standards which cover that other part. If there are no available standards, it is up to the economic operator to cover the risks, so that the product cannot present a hazard. 

Furthermore, a (harmonised) standard may not cover all the requirements described in the legislation. There are also standards that only cover part of the risks. It is therefore possible that several (harmonised) standards must be applied for product legislation. In addition, it is common that a product has to comply with different types of product legislation. 

An example:
Some time ago, 'fidget spinners' were all the rage. Within a short time, several versions were offered on the market. For example, a fidget spinner with an LED light that was powered by a battery. If the battery was not included, such a 'simple' product must at least comply with:
  • General Product Safety
  • Safety of Toys 
  • RoHS (Restriction of Hazardous Substances in Electrical and Electronic Equipment)
  • EMC (Electro Magnetic Compatibility).  
  • WEEE (Waste of Electrical and Electronic Equipment
  • REACH (Chemical legislation)

Newer standards than harmonised standards

As described above, the process of arriving at a harmonised standard can be quite complex. In addition, standards are regularly reviewed to see if they are still up to date.
From the moment of publication, a new standard may be used. However, this does not mean that this new version is automatically harmonised. This requires (again) that the EC approves and publishes it in the OJEU. It is therefore likely that at some point several versions of a standard will exist that may be used. There is often a long transitional period, especially if the differences between the two successive editions are significant and lead to adjustments of a product design.
 

Which standard to apply?

The use of the 'old' harmonised standard gives a presumption of conformity, the newer one does not (yet). Which standard should you apply to your product? 
There is of course a reason why the standardisation organisation has published a new standard. It probably has to do with the current state of technology and advancing insights. It is therefore likely that the new standard will fit a product better than the old one. It is also likely that a new standard will also be harmonised and that the old one will no longer be. The application of the new standard is therefore sensible. 
However, there may also be good reasons to apply the 'old harmonised' standard for a while. Often, this will be the case with products that have already been put on the market and for which a new batch has been ordered. Adjustments to the product may be undesirable in order to bring it in line with a new standard. 
 
Once the new standard is published in the OJEU, a date of cessation of presumption of conformity of the old harmonised standard will also be given. We call this "Date of Withdrawal", or "DOW". 

The list of applicable legislation and standards that can be used to demonstrate conformity, that you will see in ProductIP, can (therefore) differ, depending on the date that a product is placed on the market, the 'Market Release Date'. A delay in placing a product on the market may therefore mean that the product no longer complies with the applicable standard(s). 

More on this subject can be found here: https://www.productip.com/kb/productipedia/compliance-resources/market-release-date

Are all standards equally important?

Just as there are different organisations that create and publish standards, there are also differences within the standards. The following are distinguished:
  • Fundamental standards. These usually contain terminology, instructions and symbols. 
  • Test and analysis standards. These contain test methods and standards for analysis. They are used to determine certain properties of a product. 
  • Specification standards. These standards define characteristics of a product (product standards) or a service and the corresponding performance thresholds. These may include fitness for use, interface, interoperability, health and safety
  • Organisational standards. These standards describe functions and relationships of business. They are used in quality management, maintenance, production management, system management, etc. 

What are the minimum standards to meet?

A frequently asked question is what minimum standards a product must comply with. The ProductIP system categorises different types of standards into different categories. In general one can say that you should first focus on categories A and B. You can read more about the different categories of standards here: https://www.productip.com/kb/productipedia/compliance-resources/productip-requirement-categories.
 

Are standards free of charge?

No. As you have read, standards are drawn up and written by committees for CEN and CENELEC. These documents are subject to intellectual property rights. So, just like a book, you have to pay for a standard. And just like with books, the costs can vary enormously. Exceptions are the ETSI standards, which are free.

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