Consumers enjoy the same level of health, safety, and environmental protection throughout the entire eea. Emc directive no 89336eec, may 1989 amd no 9231eec, april. Directive 9368ec introduced the harmonized provisions related to ce marking. Guide on directive 75107eec measuring container bottles page 2 of 28. Council directive 90429 eec laying down the animal health requirements applicable to intracommunity trade in and imports of semen of domestic animals of the porcine species. Welmec is a cooperation between the legal metrology authorities of. European commission dg entri4 2 toys only essential safety requirements defined in the directive detailed technical specifications in. Directive 201468eu on pressure equipment specifies the essential requirements the product must meet in order for the manufacturer to affix the ce marking. Nsw australia, declare under our sole responsibility.
B council directive 9342eec of 14 june 1993 concerning. Commission directive 200543ec of 23 june 2005 amending the. Directive 200868ec of the european parliament and of the council of 24 september 2008 on the inland transport of dangerous. Emc directive no 89336eec, may 1989 amd no 9231eec. Businesses know that products bearing the ce marking can be traded in the eea without restrictions. Directive of the european parliament and of the council laying down rules on nominal quantities for prepacked products, repealing council directives 75106eec and 80232eec, and amending council directive 76211eec. Council directive 7323 eec of 19 february 1973 on the harmonization of the laws of the member states relating to electrical equipment designed for use within certain voltage limits 18. Technical guidance document in support of commission directive 93 67 eec on risk assessment for new notified substances and commission regulation ec. Regulation eec no 1612 68 of the council of 15 october 1968 on freedom of movement for workers within the community official journal l 257, 19101968 p. Our policy towards the use of cookies techstreet, a clarivate analytics brand, uses cookies to improve your online experience. Directive 93 103ec work on board fishing vessels of 23 november 1993 concerning the minimum safety and health requirements for work on board fishing vessels thirteenth individual directive within the meaning of article 16 1 of directive 89391 eec directive 92104 eec mineralextracting industries. Evaluation of council directive 9283eec european commission 5. The medical devices directive aims to ensure the free movement of goods within the community, while providing patients, users and third parties with a high level of protection and attaining the levels of performance attributed to.
Ce marking under the construction products directive. This declaration relates to and in conformity with the following standards. Van leeuwen and others published technical guidance document on risk assessment in support of commission directive 9367eec on. Council directive 90425eec of 26 june 1990 concerning. Council directive 90425eec of 26 june 1990 concerning veterinary and zootechnical checks applicable in intra community trade in certain live animals and products with a view to the completion of the internal market official journal l 224, 18081990 pp. This free of charge application was designed to help manufacturers, consultants, notified bodies to keep under control the eu declaration of conformity. Following the provisions of directive s applicable low voltage directive no 7323 eec, february 1973 amd no 93 68 eec, july 1993 emc directive no 89336 eec, may 1989 amd no 9231 eec, april 1992 and no 93 68 eec.
Council directive 9275eec of 22 september 1992 on the indication by labelling and standard product information of the consumption of energy and other resources by household appliances the council of the european communities, having regard to the treaty establishing the european economic community, and in particular article 100a thereof. Commission directive 93110ec of 9 december 1993 amending some annexes to the directive 7793eec on protective measures against the introduction into the community of organisms harmful to plants or plant products and against their spread within the community. Commission directive 200543ec of 23 june 2005 amending the annexes to council directive 68 193 eec on the marketing of material for the vegetative propagation of the vine the commission of the european communities, having regard to the treaty establishing the european community, having regard to council directive 68 193 eec of 9 april 1968. Van leeuwen and others published technical guidance document on risk assessment in support of commission directive 9367eec on risk assessment for new notified substances. The medical devices directive aims to ensure the free movement of goods within the community, while providing patients, users and third parties with a high level of protection and attaining the levels of performance attributed to the medical devices. These directives deal with marking and quantity control of emarked prepackages. Where, for machinery, the risks are mainly of electrical origin, such machinery shall be covered exclusively by directive 7323 eec where, in the case of machines, it cannot be established that the risks are mainly of electrical origin, both the machinery and the lvd directives apply in a. Ce marking, the latter shall indicate that the devices are also presumed to. Commission directive 9367eec of 20 july 1993 laying down. Directive 200965ec of the european parliament and of the.
Ce marking ce mark, eu council directive 89106eec of 21. The ce marking directive 9368eec ce marking association. B council directive 9342eec of 14 june 1993 concerning medical devices oj l 169, 12. Technical guidance document in support of commission. Evaluation of council directive 9283 eec european commission 5.
Ce marking is a part of the eu s harmonisation legislation, which is mainly managed by directorategeneral for internal market. Reduced rates for lowstrength alcoholic products 5. Other directives and regulations prescribing harmonized european standards. When the ce marking is reduced or enlarged, the proportions given in the above image have to be maintained. Regulation eec no 161268 of the council of 15 october 1968 on freedom of movement for workers within the community official journal l 257, 19101968 p.
Annex iii means annex iii to council directive 67548eec as lastly amended by commission directive 9898ec of 15 december 1998 and which for. Overview eu directives and guidelines concerning the eu dental market 2082007 subject. This free of charge application was designed to help manufacturers, consultants, notified. Regulation eec no 161268 of the council of 15 october 1968. Having regard tothe treatyestablishing the european economic community, andin particulararticle 100a. Guidance 14 guidance on ec directive 9338eec water, energy, transport and communication as amended by ec directive 984ec virtually every contract let by government is subject to ec legislation. This directive was implemented into the uk law by the utilities supply and works regulations 1995. Amalgam dental amalgam a report with reference to the medical devices directive 9342eec, ad hoc working group mandated by dg iii of the ec, 1998. Pdf technical guidance document on risk assessment in. Please find below a list of the ce marking directives and regulations european union directivesregulations that require the affixing of a ce mark to the products covers by them. Directive 93 42 eec on medical devices mdd specifies general requirements that the product has to meet in order for the manufacturer to affix the ce marking. These directives have recently been amended by directive 200745ec of 5 september 2007, which revokes directives 75106 eec and 80232 eec and amends directive 76211 eec. These ce marking can be regarded as the product trade passage for europe and many other countries worldwide who also accept and follow to ce mark requirements.
Having regard tothe treatyestablishing the european economic community, andin particulararticle 100a thereof, having regard tothe proposalfrom thecommission, in cooperation withthe2 european parliament, having regard tothe opinion oftheeconomic andsocial committee3, whereas the council has already adopteda series of. The ce marking must be affixed in the immediate vicinity of the name of the manufacturer or his authorised representative, using the same. Imq regulation for the certification of medical devices ce marking directive 9342eec as amended reference reg. Directive 9395eec and article 7 of council directive 9368eec of.
Low voltage directive, 7323 eec, the emc directive, 89336 eec, including amendments by the ce marking directive, 93 68 eec product type designation. Council directive 7323eec of 19 february 1973 on the harmonization of the laws of the member states relating to electrical equipment designed for use within certain voltage limits 18. Council directive 90429eec laying down the animal health requirements applicable to intracommunity trade in and imports of semen of domestic animals of the porcine species. You can download the complete directive in pdf by cliquing. Technical documentation, usually referred to as the technical file, relating to the product.
Regulation eec no 230993 council regulation eec no 230993 of 22 july 1993 laying down community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a european agency for the evaluation of medicinal products oj no l 214 of 24. Directive 89336eec,2 amended by directives 91263eec3, 9231eec4, 9368eec5 and 9397eec6 concerning electromagnetic compatibility, with a view to compiling a guide for use in conjunction with the directive. Establish declaration of conformity and technical construction file. Overview eu directives and guidelines 2082007 concerning. The ce marking is only required if a product is covered by one or more ce marking directives or regulations. The medical devices directive aims to ensure the free movement of goods within the community, while providing patients, users and third parties with a high level of protection and attaining the levels. Commission directive 93 67 eec of 20 july 1993 laying down the principles for assessment of risks to man and the environment of subtances notified in accordance with council directive 67548 eec. Commission directive 9367eec of 20 july 1993 laying down the principles for assessment of risks to man and the environment of subtances notified in accordance with council directive 67548eec. Manufacturers must not affix ce marking to products that dont fall under the scope of one of the directives providing for its affixing.
Council directive 91 263 eec of 29 april 1991 on the approximation of the laws of the member states concerning telecommunications terminal equipment, including the mutual recognition of their conformity 16. B council directive 9275eec of 22 september 1992 on. The directive ceased to be in force on 31 may 2015 and was repealed by regulation ec no 12722008 of the european parliament and of the council of 16 december 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing directives 67548eec and 199945ec, and amending regulation ec no 19072006 text. Intended to clarify the conditions covering the fixing of the ce marking itself, the additional information that should accompany the marking, and the content o. Ce marking ce mark, eu council directive 89106eec of. Certain directives such as the council directive 93 42 eec for medical devices as amended by directive 200747ec5, has a requirement that the manufacturer appoints an authorized representative in the european union, that is in a position to provide the technical file on request of a market surveillance authority. Council directive 93 42 eec of 14 june 1993 concerning medical devices.
These are the socalled essential requirements that are listed in annex i to the mdd. En 55012 is applicable for giving presumption of conformity under directive 89336eec for those vehicles, boats and internal combustion enginedriven devices that are not within the scope of directives 9554ec, 9724ec or 20002ec. The components of the ce marking must have approximately the same height, namely minimum 5 mm. The commission of the european communities, having regard to the treaty establishing the european economic community. Emc directive no 89336eec, may 1989 amd no 9231eec, april 1992 and no 9368eec. Ce directives pdf active implantable medical devices directive 90385 eec cableway installations directive 20009ec construction products regulation 3052011eu electromagnetic compatibility directive 201430eu environmental design for energyrelated products directive 2009125ec. Official journal of the european communities, must be given in the documents. Ce marking has been introduced by the council directive 9368eec of 22 july. Directive 93103ec work on board fishing vessels of 23 november 1993 concerning the minimum safety and health requirements for work on board fishing vessels thirteenth individual directive within the meaning of article 16 1 of directive 89391eec directive 92104eec mineralextracting industries. Ce marking is a certification mark that indicates conformity with health, safety, and. Technical guidance document in support of commission directive 9367eec on risk assessment for new notified substances and commission regulation ec. Toys directive 88378 eec of 3 may 1988 as amended by 93 68 eec of 22 july 1993. Technical guidance document in support of commission directive 9367eec on risk assessment for. It is very common when searching for guidance on ce marking to come across the ce marking directive 9368eec and it often causes confusion, as its.
The european directive 9368eec regulates and harmonizes the use of ce mark logotype and the process of ce marking for products. Official journal no page date m1 directive 9879ec of the european parliament and of the council of 27 october 1998 l 331 1 7. It is very common when searching for guidance on ce marking to come across the ce marking directive 93 68 eec and it often causes confusion, as its purpose is not overly clear. In view of the breadth of the scope of the directive and the variety of products covered, it. Annex ii means annex ii to council directive 67548eec as amended by commission directive 9321eec of 27 april 1993 and which for convenience of reference is set out in. Council directive 92 42 eec of 21 may 1992 on efficiency requirements for new hotwater boilers fired with liquid or gaseous fuels 17. It is very common when searching for guidance on ce marking to come across the ce marking directive 9368eec and it often causes confusion, as its purpose is not overly clear. The ce marking directive 9368eec it is very common when searching for guidance on ce marking to come across the ce marking directive 9368eec and it often causes confusion, as its purpose is not overly clear. Council directive 9342eec of 14 june 1993 concerning medical devices. Ce enec marking for europe the ce marking is a mandatory european marking for certain products group in conformance with the ce directives. Essentially it was introduced to amend existing directives for them to include the requirement to affix the ce mark. Council directive 90429eec laying down the animal health. Information forwarded pursuant to article 6 of this directive, in whatever form, is covered by professional secrecy. Commission directive 200543ec of 23 june 2005 amending the annexes to council directive 68193eec on the marketing of material for the vegetative propagation of the vine the commission of the european communities.
Directive 75106eec, as the nominal quantities will be included in the proposed directive. Guidance on ec directive 9338eec water, energy, transport. These directives have recently been amended by directive 200745ec of 5 september 2007, which revokes directives 75106eec and 80232eec and amends directive 76211eec. Regulation eec no 161268 of the council of 15 october. Intended to clarify the conditions covering the fixing of the ce marking itself, the additional information that should accompany the marking, and the content of the ec declaration and certificate of conformity. Council directive 89106eec of 21 december 1988 on the approximation of laws, regulations and administrative provisions of the member states relating to construction products this directive has been amended by the following council directives. Manufacturers internal market, industry, entrepreneurship.