Since the European Union's main aims include consumer protection and ensuring product safety, you might be forgiven for thinking that the EU's rules in those areas would be clear and straightforward. But you would be wrong. Manufacturers and distributors in Europe don't have the luxury of a single harmonised set of product safety, marking, and labelling regulations. Very often, products are not correctly marked or labelled for sale in the EU because the applicable rules are either unclear or esoteric.
In this Alert, we will examine the main mark required to designate product safety in Europe – the CE mark – and the wide range of other labelling and marking requirements that exist for different categories of products.
We have written before about the importance of understanding CE marking – i.e., an EU requirement that manufacturers of certain products must make a declaration that those products conform to relevant EU legislation. It's probably the main EU-related product marking that product producers and distributors need to understand.
The downside is that there's no single set of umbrella regulations that lists all CE marking requirements. So, to understand whether CE marking is necessary, it's important to understand any given product, identify the applicable product-specific regulations and then work back from there to check if those particular regulations impose a CE marking requirement.
However, the CE mark is not the only identification method required by EU legislation. There are a number of other marks that may be required (or may be voluntary) depending on the nature of the product in question, and it can certainly be confusing to know which ones should apply and when. This is a question that must be tackled by all businesses selling products in the EU.
What Is the Purpose of a CE Mark?
"CE" is the abbreviation of French phrase "Conformité Européene" (literally, "European Conformity"); and a CE mark is placed on products sold within the EU to declare that the product complies with all of the applicable provisions of the relevant Directives, and that it has been subject to the appropriate conformity assessment procedures. So, it relates to the regulatory compliance of physical products.
A CE mark acts as a "passport" for the use of certain products within the EU. It's a declaration by the manufacturer that the product in question complies with all relevant EU legislation. Member States are not allowed to restrict the marketing and use of CE marked products, unless there is evidence of non-compliance justifying such restriction.
In many cases, the EU Directives that impose product-type specific requirements also impose an obligation to:
- CE mark the products;
- maintain a written declaration that the product to which the CE marking has been affixed complies with the requirements of the relevant Directives; and
- maintain a set of technical documentation which describes the product in question, contains information about the design, manufacture and operation of the product, and details the procedures followed in reaching the conclusion that the product is compliant.
So, to know whether CE marking might be required, you have to start with the right set of product-specific regulations.
A product that's not covered by a Directive providing for CE marking must not be CE marked; and, where a product is covered by several Directives that all provide for CE marking, the marking indicates that the products are presumed to conform to the provisions of all of these Directives.
The obligation for CE marking extends to all products covered by the relevant Directives, and the marking must be placed on:
- all new products, whether manufactured in the Member States or in third countries;
- used and second-hand products imported from third countries; and
- substantially modified products that are subject to Directives as new products.
As noted, there is no single EU Directive that lists all products affected by a CE marking requirement. CE marking is a legal obligation derived from EU legislation which provides that certain types of products must comply with specific standards and requirements. If a business wishes to market its products in Europe and those products are covered by the relevant EU legislation that prescribes CE marking, then a CE mark must be placed on such products as part of compliance with the applicable legal requirements.
A wide range of products are covered by EU laws that mandate CE marking. Categories of products which are subject to the CE marking requirement include:
- medical devices;
- products that have an impact on energy consumption, e.g., washing machines, tumble dryers, toasters, microwaves, hair dryers, electric toothbrushes, and other household appliances used for cooking, clothing care, and personal care; personal computers, scanners, printers, and other IT equipment "intended primarily for use in the domestic environment"; radios, video cameras, VCRs, hi-fi systems, musical instruments, and other AV equipment (but excluding televisions); and toys such as radio-controlled cars, handheld video game consoles, and other toys or sports and leisure equipment with electric or electronic components;
- products which are capable of causing electromagnetic interference or radio frequency interference (i.e., most electrical and electronic goods);
- radio equipment and telecommunications terminal equipment;
- electrical goods which operate in a low voltage range.
CE marking is NOT a "certification" process, it is a "self-declaration" process. To be entitled to affix the CE mark, a manufacturer must test and ensure that a product meets all of the relevant "Essential Requirements" of all of the applicable CE marking Directives, and prepare and retain Declarations of Conformity, Incorporation, and Performance.
Where the CE regime applies, it's not just enough to affix the CE mark. The manufacturer must back that up with appropriate testing to ensure that the product complies with the applicable regime and maintain a Declaration of Conformity for up to 10 years from the date of placing the product on the market.
There are mechanisms in place to ensure that the CE marking is put on products correctly. Controlling products bearing CE marking is the responsibility of public authorities in EU Member States, in cooperation with the European Commission. Citizens may contact national market surveillance authorities if the misuse of the CE marking is suspected or if a product's safety is questioned.
In practice, the mechanisms that apply to enforcement of the CE marking process vary among Member States. Penalties typically include a fine and, in some circumstances, imprisonment. However, if the product is not regarded as an imminent safety risk, a manufacturer is often given an opportunity to ensure that the product is made to conform to the applicable legislation rather than being required immediately to take the product off the market.
Other Marks and Labels
But if the CE mark is the most common form of mark that may be required for a wide range of different product types, EU legislation also requires a wide range of other marks either on specific products or to perform a specific role, including informing consumers about details concerning the products such as how they can be disposed of, their composition, or any safety concerns. Most foodstuffs, textiles, footwear, tyres and energy-related products are subject to labelling regimes.
The range of products which require specific marks includes electronic equipment, toys, cosmetics, and textiles is wide. Marks required in these fields may not come with the onerous baggage of the CE mark – because applying the mark does not require the business to prove conformity with any EU law. However, it's no less essential that businesses ensure compliance with any marks they are required to use because not doing so would, in most cases, be a breach of EU law.
This article does not attempt to provide an exhaustive list of all of the various marks that businesses might need to consider when selling certain products. But it does focus on some of the main marks and labels that might be required, with a particular focus on those which are mandatory, and may serve the purpose of showing that a product has been reviewed and approved by a trusted authority.
Waste Electrical and Electronic Equipment Directive (the"WEEE Directive")
The WEEE Directive was implemented in 2002 (and updated in 2012) in order to tackle the waste of electronic goods, encouraging instead the recycling of such goods. The WEEE Directive provides that producers appropriately mark electrical and electronic equipment placed on the market with the following symbol:
The WEEE Directive currently applies to electronic and electrical goods that fall into ten categories:
- large household appliances (e.g., freezers, dryers, refrigerators);
- small household appliances (e.g., vacuum cleaners, toasters, irons);
- IT and telecommunications equipment (e.g., printers, laptops, copying equipment);
- consumer equipment and photovoltaic panels (e.g., radio and TV sets, video cameras);
- lighting equipment (e.g., straight and compact fluorescent lamps);
- electrical and electronic tools (with the exception of large-scale stationary industrial tools);
- toys, leisure and sports equipment;
- medical devices (with the exception of all implanted and infected products);
- monitoring and control instruments;
- automatic dispensers.
However, starting in August 2018 the WEEE Directive applies to a wider range of goods. Although there are fewer categories, these encompass all the goods that were previously in the scope of the original WEEE Directive and also add: temperature exchange equipment (such as radiators, freezers, and air conditioning equipment); and screens, monitors, and equipment containing screens covering more than 100 cm2.
The Energy Labelling Directive applies to energy-related products, defined in the Directive as "a good or system with an impact on energy consumption during use which is placed on the market or put into service".
Such products must be labelled to show their energy efficiency, using a form like the one below which is a pro forma label prescribed for fridge-freezers.
Marking on textiles is mandated by the Textile Regulation. Unlike some of the marks required by other EU legislation, the Textile Regulation does not prescribe a specific image or mark to be affixed to certain products. Rather, the Textile Regulation provides that products shall be labelled or marked to give an indication of their fibre composition whenever they are made available on the market. The labelling and marking of textile products must be: durable, easily legible, visible and accessible and, in the case of a label, securely attached.
As well as being CE marked, equipment for use outdoors must also provide an indication of guaranteed sound power levels. This indication must consist of: a single number of the guaranteed sound power in decibels (dB), the sign LWA and a pictogram taking the following form:
Toy Safety Directive
As one might expect, the Toy Safety Directive requires producers of toys to provide certain information where toys may not be suitable for certain children, or where toys should be used with any added caution. The Toy Safety Directive states that warnings should specify appropriate user limitations where warranted. In its Annex V, the Directive sets out various warnings to be used in different scenarios. These are generally word warnings rather than image marks: for example, functional toys must include the warning "to be used under the supervision of an adult". One circumstance in which an image mark must be used relates to toys that are not suitable for children under six months of age, which must be affixed with the following symbol:
The Toy Safety Directive also states that the manufacturer shall mark the warnings in a clearly visible, easily legible and understandable, and accurate manner on the toy, on an affixed label, or on the packaging and, if appropriate, on the instructions for use which accompany the toy.
The Cosmetics Regulation states that cosmetic products shall be made available on the market only where the container and packaging of cosmetic products bear a number of pieces of information in indelible, easily legible, and visible lettering. Such information includes the name and address of the responsible person to whom enquiries about the product can be made; the nominal content of the packaging; particular precautions to be observed in use; the function of the cosmetic product; and a list of ingredients.
The Cosmetics Regulation also provides that certain image marks should be used. The following symbol should be used alongside the expiration date on the product:
Similarly, where a product's minimum durability is longer than 30 months, there should be an indication of the period of time when the product is safe to use once it has been opened. This should be accompanied by this symbol:
Perhaps one of the symbols most commonly seen on consumer products is the e-mark (shown below). The e-mark applies to pre-packaged goods, and represents a guarantee that certain liquids and other substances have been packed by weight or volume in accordance with two EU Directives: one on filling packages, the other on glass bottles. Such compliance (and therefore use of the e-mark) is not mandatory, but the e-mark acts as a "passport" which allows the free movement of the relevant goods throughout the EU, and can therefore be particularly useful for those looking to sell pre-packaged goods within the EU's single market.
The List Doesn't End There...
A number of other groups of products require marks in certain circumstances. Some examples include:
- devices to be used in a potentially explosive atmosphere;
- dangerous or hazardous substances;
- automotive vehicles and tyres;
- footwear; and
- marine equipment.
With such a wide range of goods that require some sort of marking when distributed or sold on to the EU market, it's essential that businesses stay on top of any legislation that may apply to the goods they produce, and seek advice if unsure.
What About All of These Other Marks?
If you inspect your laptop charger – or indeed many other electronic goods you may have – you will likely see a number of symbols and letterings. These largely denote certification that has been received from independent, state-approved entities, Nationally Recognised Testing Laboratories (NRTLs), which test various goods and ensure compliance with both individual criteria set by the manufacturer, and other local or international standards. One such entity is TÜV – a company based in Germany, which tests a variety of goods, including technical equipment, capital goods, durable goods, and consumer goods, in order to ensure compliance with European and International standards. BSI offers a similar service in the UK, as does Underwriters Laboratory (UL) from Chicago, Illinois.
In many cases, these entities will test products to ensure compliance with EU legislation so that a CE mark can be applied. The mark of the entities themselves can then also be affixed to show that testing has been done to a particularly high standard. This differs from the other marks or symbols in this article in that certain hurdles must be cleared in order for certification to be obtained, and subsequently for the symbol to be affixed to the relevant product. While such testing is an added expense, it can be a useful tool in assuring customers and regulatory authorities that the manufacturer has gone above and beyond in ensuring maximum compliance.
Products from businesses that operate on a global scale will also contain marks which are required for other jurisdictions. For example, CCC is a symbol to represent compliance with China Compulsory Certification, China's equivalent to a CE mark.
Examples of UL and TÜV symbols, denoting certification from these bodies
CE marks form an essential part of selling certain products within the EU, and – as we described in our previous article – businesses should be certain that they have identified the products which need CE marks and comply accordingly – perhaps using state-approved NRTLs to conduct testing. The other wide-ranging marks explored in this article are undoubtedly less onerous to use than CE marking, in that they are informational and therefore do not require the manufacturer to show conformity with any particular legislation that requires a label to be affixed to a product. However, they are no less important – the symbols and marks are often required by EU law, and failure to affix them properly will constitute a breach of that law. Therefore, as with CE marking, businesses should be certain that where they sell products in the EU, they keep up-to-date with all marking requirements or information that they need to provide to consumers, and do so accordingly.
Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.
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