Doesn’t matter if you check out importer’s legal obligations, you plan to develop new product and have it mass produced under your own brand or you look at an item as a plain consumer (which we all are at the end of the day). CE mark is THE mark for all EU marketed goods and it’s worth to know its rules.
WHAT IS CE MARK, WHAT IS ITS MEANING?
You go to a store and you find it on a product. What does the symbol tell you? That every EC legislation that applies to this product has been followed. Since the mark is placed there by the manufacturer – it is the manufacturer that guarantees that.
CE marking is a perfect solution – solves all the problems with one cut. All legal requirements that apply to the product – are met. Ergo it can be legally sold throughout the Community countries.
From the consumer point of view: Makes consumer’s life easier, doesn’t it? Any questions that may arise in consumer’s mind: has this product been properly tested? has anyone assessed its safety? – the answer is CE. CE = yes, product has all the necessary tests, safety assessments and certificates required by the Community law applicable for this specific kind of products.
From the entrepreneur point of view: it creates liability. The entrepreneurs must be aware which of the regulations are applicable for their products and learn if their requirements are met.
Typical requirements refer either to the product itself, such as:
- chemical compound (content)
- chemical substance release rate
- physical characteristics
or to the production process, such as:
- production auditing
- inline testing
- sampling schemes
or to the conformity assessment procedures.
WHERE DOES THE CE MARK COME FROM AND WHERE ONE CAN FIND IT? RULES OF AFFIXING.
No matter what way the product needs to go through to be deemed as compliant with all applicable requirements – it’s always the manufacturer (or its authorized representative) that affixes the mark. It is the manufacturer who places the mark and it’s him who takes responsibility for the product’s compliance and safety.
CE mark, in form as presented in Annex II to the 765/2008 Regulation, shall be affixed visibly, legibly and indelibly to the product or to its data plate. The general rule is that it shall be at least 5mm high. What if product’s size or nature doesn’t allow such affixing? It needs to be affixed at least on the packaging + any accompanying documents. The important thing is for the consumer to see it when making his mind about the purchase.
CE mark can be followed by:
- a pictogram or any other mark indicating special risk or use
- number of identification of notified body – if such was taking part in production control or conformity assessment process
- two last figures of the year in which it was affixed
- other additional marking required by any specific harmonized legislation
CE ONLY FOR THE CHOSEN ONES
As art. 30 (2) states: “The CE marking (…) shall be affixed only to products to which its affixing is provided for by specific Community harmonisation legislation, and shall not be affixed to any other product.” In other words, where specific legislation say that certain kind of product (for example sunglasses) shall carry the CE mark – then CE mark must be affixed (if it’s not – it cannot be placed on European market ). But if specific legislation does not require the CE marking – it’s illegal to put the mark on the product. Why we don’t find CE mark affixed to any type of product? Because. I have no better explanation for that except that the legislator said so…. It may change in the future. But for now you surely shouldn’t find the marking on: foodstuff, chemicals, pharmaceuticals and cosmetics. Whereas if you don’t find in on your laptop, wristwatch or your child’s toy – you shall be alerted.
BREAKING THE CE RULES
What happens if CE mark is placed on a product that:
- hasn’t even gone through conformity assessment process
- has gone through the process but doesn’t meet the all the requirements set out in harmonized legislation
- is of such kind that is not supposed to be CE marked?
These products shall not be placed on the EU market. They could be restricted or prohibited from making available on the market, withdrawn or recalled – depending on which stage of market placing the misleading CE marking has been noted by the authorities and what other requirements have been infringed. It’s conveniently executable in case of import – such non compliance should be caught by the external border controls. For any products – those imported or those produced within the European Community – such non compliance would be handled by market surveillance authorities.
What one shall remember is that regulation 765/2008 in art. 30 (6) says such infringements shall be penalized, including criminal sanctions for serious offences.
The EU regulation puts serious obligation onto entrepreneurs (so called economic operators) – to handle their products with at least due diligence. Let’s hope they’ve taken adequate responsible approach. At certain point we all can find ourselves to be the final users.
- This is general rule, set out in art. 30 of Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008.
- Modules of conformity assessment procedures are drafted in Annex II o Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008.
- Rules of affixing CE mark are set out in art. R12 of Annex I to Decision No 768/2008/EC.
- The liability is shared with other economic operators (such as importers, distributors etc.) proportionally to their role in supply chain and according to the degree and way of impacting the product on each particular stage of supply chain.
- EEA countries