5.2.1 CE Marking
The CE marking symbolises the conformity of the product with the applicable Community requirements imposed on the manufacturer. This requirements emanate from a number of product safety directives, including the Directive on general product safety, the EMC Directive, the low voltage Directive and the Directive on toys (all these have been dealt with in this Business Guide). There is no equivalent of the CE marking at only national level, as the CE marking applies throughout the Community in a fully harmonised manner.
The CE marking is mandatory and must be affixed before any product subject to it is placed on the market and put into service (save where specific directives require otherwise). Where products are subject to several directives, which all provide for the affixing of the CE marking, the marking indicates that the products are presumed to conform to the provisions all these directives.
A product may not be CE marked, unless it is covered by a directive providing for its affixing. The obligation to affix the CE marking extends to all products within the scope of directives providing for its affixing, and which are intended for the Community market. Thus, the CE marking must be affixed:
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to all new products, whether manufactured in the Member States or in third countries;
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to used and second-hand products imported from third countries; and
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to substantially modified products that are subject to directives as new products.
The manufacturer, whether established inside or outside the Community, is the person ultimately responsible for the conformity of the product with the provisions of the relevant directive and for the affixing of the CE marking. The manufacturer may appoint an authorised representative established in the Community to act on his behalf. The person responsible for placing the product on the market may, exceptionally, be deemed to have assumed the responsibilities of the manufacturer.
The CE marking shall, as a rule, be affixed to the product or to its data plate. In addition, it can be affixed, for instance, to the packaging or to the accompanying documents. However, it may exceptionally be moved from the product or its data plate if this rule cannot be followed. This would be justified where affixing it to the product was impossible (for example on certain types of explosives), or not possible under reasonable technical or economic conditions, or where the minimum dimensions could not be respected, or it could be ensured that the CE marking was visibly, legibly and indelibly affixed. In such cases, the CE marking has to be affixed to the packaging, if it exits, and to the accompanying document, where the directive concerned provides for such documents the CE marking on the product may neither be omitted nor be moved to the packaging or accompanying documents on purely aesthetic grounds.1
5.2.2 Origin Marking
Hong Kong traders familiar with the EU market will know that, generally speaking, there is no EU law requiring commonly used consumer (non-edible) goods to bear marks indicating their origin2, nor is there a law preventing voluntary origin marking where traders wish to do so. However, in the event that such marks are applied to goods, the competent authorities of the Member States will require these marks to be accurate. It is, indeed, considered an offence for a supplier to apply false or misleading descriptions to goods, including as regards their origin.
Some Member States and some sectors (particularly those of interest to mainland traders) have nonetheless been pushing the European Commission to introduce a proposal for EU-wide legislation, which would make origin marking ("made in [...]") compulsory for at least some commonly sold products, including textiles and footwear.
The Commission has, accordingly, presented a proposal on 16 December 2005, for a Council Regulation on the indication of the country of origin of certain products imported from third countries. The proposed Regulation applies to the categories of product laid down in its Annex (reproduced in the table below), if these are manufactured outside the EEA (EU plus Norway, Iceland and Liechtenstein), Bulgaria, Romania and Turkey. In consequence, Hong Kong and Chinese mainland goods are covered.
Goods that require origin marking may nonetheless be exempt where, for technical or commercial reasons it appears impossible to mark them. It should be kept in mind that the terms "origin" and "originating" refer to non-preferential origin in accordance with the Community Customs Code. Furthermore, the proposed Regulation will not apply to goods of a non-commercial nature contained in travellers' personal luggage.
The proposed Regulation requires that the country of origin must be marked on the goods covered by it, and where they are packaged then the marking shall be made separately on the package. The words "made in [country-of-origin]" will have to appear in an official language of the EU which is easily understood by final customers of the Member State in which the products are to be marketed. The marking has to be clearly legible and indelible; must be visible during normal handling; markedly distinct from other information; and not be misleading. Furthermore, the Commission will be given the power to adopt implementing measures which could further determine other details of origin marking; establish a list of commonly used terms or abbreviations; and establish for which goods marking is not needed.
The Member States will have to the competence to determine the applicable penalties for failure to comply with the future Regulation. The proposed Regulation, being simply a "Council Regulation", does not have to be approved by the European Parliament. Thus, its adoption will occur at a more rapid pace than in the case of most other technical regulations and directives.
The proposal states that the Regulation will enter into force at the EU level on the twentieth day following its publication in the Official Journal. As for the actual marking requirements, these will have to be implemented by producers 12 months after entry into force of the Regulation, subject to the Commission extending this period, in case it comes up with further implementing measures which will then provide producers with more time for compliance.
The Annex to the Proposed Regulation
5.2.3 General Product Safety (Directive 2001/95/EC)
The General Product Safety Directive (GPSD) is complementary to specific product safety legislation. Where consumer products are covered by sector-specific legislation (e.g. toys), those provisions take priority over the general provisions of the GPSD (in accordance with the lex specialis principle).
The relevant provision of the GPSD for the purposes of comparison with the labelling, packaging and marking requirements contained within certain sector specific legislation is Article 5(1). This Article obliges producers to provide consumers with relevant information on the risks inherent in a product, where such risks are not immediately obvious without adequate warnings. The objective is to enable consumers to assess these risks and to take precautions against them.
Three sectors which are of particular interest to Hong Kong businesses will now be examined.
5.2.4 The Safety of Toys (Directive 88/378/EC)
Directive 88/378/EC, published on 7 June 1988 and as amended by Directive 93/68/EC, contains specific provisions on the labelling, marking and packaging of toys. Thus, these sector specific provisions take precedence over Article 5(1) of the GPSD.
Article 3 of the Toys Directive obliges Member States to take all steps necessary to ensure that toys cannot be placed on the market unless they meet the essential safety requirements set out in Annex II to the Directive. Annex II contains the "essential safety requirements for toys" and includes requirements in relation to, among others:
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the physical and mechanical properties of toys;
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the flammability of toys;
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the chemical properties of toys; and
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the electrical properties of toys.
Of more importance for the purposes of labelling, marking and packaging are Article 11(5) of, and Annex IV to, the Directive. Together, these provisions ensure that toys are accompanied by appropriate clearly legible warnings in order to reduce inherent risks in their use, as described in the essential requirements. In particular:
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toys which might be dangerous for children under 36 months of age must bear a warning as such;
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slides and similar toys must be accompanied by instructions drawing attention to the need to carry out regular checks and maintenance of the main parts;
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functional toys or their packaging must bear a marking advising use under the direct supervision of an adult;
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toys containing inherently dangerous substances must bear a corresponding warning;
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skates and skateboards must bear a warning regarding protective equipment; and
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toys intended for use in the water must contain a warning.
5.2.5 Electrical Equipment Designed for Use within Certain Voltage Limits (Directive 2006/95/EC)
Directive 2006/95/EC contains specific provisions on the labelling, marking and packaging of electrical equipment designed for use within certain voltage limits (LVD). Thus, these sector specific provisions take precedence over Article 5(1) of the GPSD.
The LVD obliges Member States to take all appropriate measures to ensure that electrical equipment is placed on the market only if it does not endanger safety when properly installed and maintained and used in applications for which it was made. Annex 1 to the Directive sets out the principal elements of these safety objectives, which include:
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the essential characteristics of the electrical equipment must be marked on the product or on an accompanying notice;
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the manufacturer or brand name or trade mark should be clearly printed on the product or on the packaging; and
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the product and its parts should be made in such a way as to ensure that it can be safely and properly assembled and connected.
5.2.6 Cosmetic Products (Directive 76/768/EEC)
Directive 76/768/EEC, which was published on 27 September 1976 and as most recently amended by Directive 2005/42/EC, contains specific provisions on the labelling, marking and packaging of cosmetic products. Thus, these sector specific provisions take precedence over Article 5(1) of the GPSD.
Article 2 of the Directive provides that a cosmetics product which is placed on the EU market must not cause damage to human health when applied under normal or reasonably foreseeable conditions of use, taking account, in particular, of the product's presentation, its labelling, and any instructions for its use and disposal.
Under Article 6(1) of the Directive, Member States are obliged to ensure that cosmetics may only be marketed if the container and packaging bear certain specified information in indelible, easily legible and visible lettering. This information includes, for example:
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contact details of the manufacturer;
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the function of the product, unless that is clear;
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a list of ingredients;
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the best before date; and
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particular precautions to be observed in use, as set out in Annexes III, IV, VI and VII to the Directive.
| 1 |
European Commission's Guide to the implementation of directives based on the New Approach and the Global Approach. |
| 2 |
Origin marking is required for consumer goods in Italy; please see section on Italy below. |