Introduction
I don’t know how many times I have heard words from distributors, buyers, politicians, clinics, etc. in the EU anxious to sell or buy new products saying, not to worry you don’t have to CE Mark your products for the EU. The first time was several years ago when the Mayor of a small town in Portugal wanted to assure a Michigan machinery manufacturer that he would take care of the CE Marking issue. Of course, he could not. The Mayor was so excited that a large US manufacturer was going to locate a new plant near his town he didn’t want anything to interfere with the process. The Michigan manufacturer had an order to deliver a machinery assembly line to manufacture fuel injection systems for an automobile plant. They were aware that CE Marking was required for machines.
Not too long before another Michigan manufacturer had shipped a non CE Marked machine to a plant they owned in Northern Ireland. A workman spotted the machine and reported it to his foreman as required by the EU Workplace Safety Act who then reported it to the British Government.
When the company was informed of their transgression, they said that it was their machine built in their Michigan plant and it was to be installed in their Northern Ireland plant so they asserted it didn’t have to be CE Marked. British authorities reminded the company that their plant was on sovereign British soil subject to UK & EU law. They gave the plant manager a six month suspended sentence under the Criminal Code, fined the company, told them to remove the machine until it complied with the Machinery Directive and said never do it again.
Placing A Product On The EU Market
The operative words in all EU New Approach Directives are very clear. For Example, the new Toy Safety Directive 2009/48/EC of 18 June 2009 states:
Chapter I
General Provisions
Article 1
Subject Matter
This Directive lays down rues on the safety of toys and on their free movement in the Community.
Article 2
Scope
1. This Directive shall apply to products designed or intended, whether or not exclusively, for use in play by children 14 years of age (hereinafter referred to as toys).
Article 3
Definitions
For the purposes of the Directive, the following definitions shall apply:
1. ’making available on the market’ means any supply of a toy for distribution, consumption, or use on the Community market in the course of commercial activities, whether in return for payment or free of charge. (emphasis added in bold print)
2. ’placing on the market’ means the first making available of a toy on the Community market. (emphasis added in bold print)
The same language can be found in all of the CE Marking new approach Directives. Any product that requires CE Marking, whether for payment or free, must be CE Marked. The liability for failing to CE Mark a product falls on the manufacturer, not the buyer.
In the new Toy Safety Directive 2009/48/EC, the EU has set forth:
- Article 7, Obligations of distributors
- Article 8, Cases in which obligations of manufacturers apply to importers and distributors
- Article 9, Identification of economic operators
While its nice to see the EU set forth legal expectations for Distributors, Importers and Economic Operators, this does not take the “monkey off the back” of manufacturers. If a manufacturer places a non-marked product on the EU market that should have a CE Mark, that manufacturer is legally liable.
What is the Legal Liability for Failing to CE Mark a Product?
The new Toy Safety Directive spells out several steps that can be taken for placing a toy on the market that should be CE Marked;
- Chapter VI sets forth the “Obligations And Powers Of Member States”
- Article 39 establishes the “Precautionary Principle”
- Article 40 establishes the “General Obligation To Organize Market Surveillance” in accordance with Articles 15 to 29 of Regulation (EC) No 765/2008 of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and Repealing Regulation (EEC) No 339/93
- Article 41 sets forth “Instructions to the notified body”
- Article 42, Procedure for dealing with toys presenting a risk at national level
- Article 43, Community safeguard procedures
- Article 44, Exchange of information – Community Rapid Information Exchange System
Finally, Article 45 defines what is meant by Formal non-compliance:
1.Without prejudice to Article 42, where a Member State makes one of the following findings, it shall require the relevant economic operator to put an end to the non-compliance concerned:
(a) that the CE marking has been affixed in violation of Article 16 [General principles of the CE marking] or 17 [Rules and conditions for affixing the CE marking];
(b) that the CE marking has not been affixed;
(c) that the EC declaration of conformity has not been drawn up;
(d) that the EC declaration of conformity has not been drawn up correctly;
(e) that the technical documentation is either not available or complete.
2. Where the non-compliance referred in paragraph 1 persists, the Member State concerned shall take appropriate measures to restrict or prohibit the toy being made available on the market, or shall ensure that it is recalled or withdrawn from the market. (emphasis added in bold print)
Summary
The reason I chose the Toy Safety Directive was a question this week from a client with whom I am working to CE Mark their products who was told by two distributors that their toy didn’t have to be CE Marked for sale in the EU. Whether the two distributors were incredibly ignorant, previously lucky in evading the law or duplicitous is beside the point they still try to persuade manufacturers to sell them non CE Marked toys. Fortunately, my clients were suspicious and suspected that the distributors were not telling the truth.
Finally, take a close look at Article 45 above, Formal non-compliance. Those of you who have been reading my recent Blogs, especially the last three posted on July 30, August 15 and August 17 respectively should recognize that the manufacturer who manufactured the machine that killed a worker in the UK and maimed another worker for life in the US did not satisfy any of these requirements! The Machinery Directive has the very same requirements as the Toy Safety Directive.
The EU has adopted excellent legislation on Market Surveillance, however, I am still concerned with the quality of implementation. I think these types of steps are essential for effective Market Surveillance for the EU new approach Directives As noted previously, I would like to work with the EU to enforce market surveillance so that consumers aren’t injured or killed. I also would like to work with European manufacturers concerning steps for them to take to reduce their liability exposure in the US market. It seems to fit the European philosophical approach to product safety and would help EU firms concerned about the litigious nature of the US marketplace. If anyone is interested in exploring these topics further, please contact me at jameskolka@gmail.com or jim@jameskolka.com.
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