2004/96/EC - Commission Directive 2004/96/EC amending Council Directive 76/769/EEC as regards restrictions on the marketing and use of nickel for piercing post assemblies for the purpose of adapting its Annex I to technical progress
Directive 2004/96/EC amends Council Directive 76/769/EEC by updating restrictions on the marketing and use of nickel in piercing post assemblies to reflect technical progress. The directive replaces the previous nickel content limit with a migration limit, based on new risk assessments indicating that controlling nickel release better reduces the risk of sensitization in humans. The migration limit is adjusted with a multiplication factor defined in the European standard EN 1811 to account for measurement variability. The European Committee for Standardisation is invited to review this standard to potentially eliminate or reduce the adjustment factor. The amendment aligns with current scientific knowledge and safety practices and complements existing worker protection laws, including those addressing carcinogenic and mutagenic exposures. Member States were required to adopt and publish compliant laws by August 1, 2005, and to apply them from September 1, 2005. The directive aims to enhance consumer safety by limiting nickel exposure from body piercing products and promotes harmonized regulatory standards across the EU.
Purpose
Directive 2004/96/EC amends Council Directive 76/769/EEC concerning restrictions on the marketing and use of nickel specifically in piercing post assemblies. The amendment aims to update Annex I of Directive 76/769/EEC in light of technical progress. The directive changes the regulatory approach from limiting nickel content in piercing post assemblies to limiting the migration or release rate of nickel, based on an updated risk assessment that concluded this migration limit better protects against nickel-induced sensitisation (allergic reactions).
Key obligations
- Nickel and its compounds must comply with a specific nickel release (migration) limit in piercing post assemblies used for body piercing.
- The migration limit uses an adjustment factor specified in European standard EN 1811 to account for inter-laboratory variation and measurement inaccuracies.
- The European Committee for Standardisation (CEN) is invited to review EN 1811, especially the adjustment factor, to potentially revise the standard with a reduced or no adjustment factor.
- Member States must adopt and publish the necessary legal, regulatory, and administrative provisions by 1 August 2005 at the latest.
- Member States must apply these provisions by 1 September 2005.
- Member States are required to communicate these measures and their legal texts to the European Commission, including a correlation table linking national provisions with this Directive.
- The Directive applies without prejudice to other Community legislation protecting worker health and safety, including Directives 89/391/EEC and 2004/37/EC related to occupational exposure to carcinogens and mutagens.
Affected products and actors
- The Directive specifically targets piercing post assemblies for use in body piercing, which are consumer products that come into direct and prolonged contact with the skin.
- Producers and importers of piercing post assemblies are directly affected, as their products must meet the nickel migration limits.
- Member States’ regulatory authorities are responsible for enforcing the restrictions and ensuring compliance.
- The European Committee for Standardisation (CEN) is tasked with reviewing and potentially revising the testing standard EN 1811.
Implementation timeline
- The Directive entered into force on the twentieth day following its publication in the Official Journal of the European Union.
- Member States had to adopt and publish implementing legislation by 1 August 2005.
- The provisions must have been applied starting 1 September 2005.
- Member States also must notify the Commission of the legal measures and provide the correlation table by the date of adoption of their national provisions.
This Directive applies specifically to piercing post assemblies that contain nickel, regulating the marketing and use of nickel in these products. It targets products intended for piercing purposes that come into direct and prolonged contact with the skin, due to the risk of sensitisation to nickel. The Directive introduces a migration limit for nickel release from these piercing post assemblies, replacing the previous content limit, to better protect consumers from nickel allergy. The scope is limited to regulating the nickel content and release in piercing post assemblies sold or marketed within the European Union, ensuring compliance with updated safety standards to reduce allergic reactions and protect public health. This Directive complements other EU legislation on worker protection and safety but focuses on consumer goods specifically made for body piercing.
General Information
This European Standard deals with all significant hazards, hazardous situations and events as listed in Clause 4 which are relevant to down cutting cross-cut saws and dual purpose down cutting cross-cut saws/circular saw benches, herein after referred to as "machines", designed to cut solid wood, chipboard, fibreboard, plywood and also these materials where they are covered with plastic edging and/or plastic/light alloy laminates when they are used as intended and under the conditions foreseen by the manufacturer including reasonably foreseeable misuse.
NOTE 1 For the definition of down cutting cross-cut saws and dual purpose down cutting cross -cut saws/circular saw benches, see 3.2.2, 3.2.3 and 3.2.4, and for the definition of displaceable machine, see 3.2.8.
This document does not apply to:
- machines for cross cutting logs;
- hand-held motor-operated electric tools or any adaptation permitting their use in a different mode, i.e. bench mounting;
NOTE 2 Hand-held motor-operated electric tools and saw benches to form an integrated whole with a hand-held motor-operated electric tools are covered by EN 60745-1:2009 together with EN 60745-2-5:2010.
- transportable machines set up on a bench or a table similar to a bench, which are intended to carry out work in a stationary position, capable of being lifted by one person by hand i.e. maximum mass ≤ 25 kg.
NOTE 3 Transportable motor-operated electric tools are covered by the requirements of EN 61029-1:2009 together with EN 61029-2-9:2009 and EN 61029-2-11:2009.
This document is not applicable to down cutting cross-cut saws and dual purpose down cutting cross-cut saws/circular saw benches which are manufactured before the date of its publication as European Standard.
- Standard62 pagesEnglish languagee-Library read for1 day
This European Standard specifies a method for simulating the release of nickel from all post assemblies which are inserted into pierced ears and other pierced parts of the human body and articles intended to come into direct and prolonged contact with the skin in order to determine whether such articles are in compliance with the Commission Regulation (EC) No 552/2009 amending Regulation (EC) No 1907/2006 on REACH as regards Annex XVII.
Spectacle frames and sunglasses are excluded from the scope of this European Standard.
NOTE Spectacle frames and sunglasses are subject to the requirements of EN 16128:2011 which provides an unchanged re-publication of the technical requirements that had previously been specified in EN 1811:1998, but restricted in scope to apply only to spectacle frames and sunglasses.
- Standard29 pagesEnglish languagee-Library read for1 day
This European Standard specifies a method for accelerated wear and corrosion, to be used prior to the detection of nickel release from coated items that come into direct and prolonged contact with the skin.
- Standard14 pagesEnglish languagee-Library read for1 day
CEN/TC - Modifications in list entries 5.8 and 5.9.
- Corrigendum2 pagesEnglish languagee-Library read for1 day
This European Standard deals with all significant hazards, hazardous situations and events as listed in Clause 4 which are relevant to down cutting cross-cut saws and dual purpose down cutting cross-cut saws/circular saw benches, herein after referred to as "machines", designed to cut solid wood, chipboard, fibreboard, plywood and also these materials where they are covered with plastic edging and/or plastic/light alloy laminates when they are used as intended and under the conditions foreseen by the manufacturer including reasonably foreseeable misuse.
NOTE 1 For the definition of down cutting cross-cut saws and dual purpose down cutting cross -cut saws/circular saw benches, see 3.2.2, 3.2.3 and 3.2.4, and for the definition of displaceable machine, see 3.2.8.
This document does not apply to:
- machines for cross cutting logs;
- hand-held motor-operated electric tools or any adaptation permitting their use in a different mode, i.e. bench mounting;
NOTE 2 Hand-held motor-operated electric tools and saw benches to form an integrated whole with a hand-held motor-operated electric tools are covered by EN 60745-1:2009 together with EN 60745-2-5:2010.
- transportable machines set up on a bench or a table similar to a bench, which are intended to carry out work in a stationary position, capable of being lifted by one person by hand i.e. maximum mass ≤ 25 kg.
NOTE 3 Transportable motor-operated electric tools are covered by the requirements of EN 61029-1:2009 together with EN 61029-2-9:2009 and EN 61029-2-11:2009.
This document is not applicable to down cutting cross-cut saws and dual purpose down cutting cross-cut saws/circular saw benches which are manufactured before the date of its publication as European Standard.
- Standard62 pagesEnglish languagee-Library read for1 day
This European Standard specifies a method for accelerated wear and corrosion, to be used prior to the detection of nickel release from coated items that come into direct and prolonged contact with the skin.
- Standard14 pagesEnglish languagee-Library read for1 day
This European Standard specifies a method for simulating the release of nickel from all post assemblies which are inserted into pierced ears and other pierced parts of the human body and articles intended to come into direct and prolonged contact with the skin in order to determine whether such items are in compliance with the European Directive 76/769/EEC as amended by 94/27/EC and 2004/96/EC. DRAFTING REMARK Subject to the final positive decision of the European Commission, CEN/TC 347/TG 1 supports the following wording to be included in the scope of this standard: Spectacle frames and sunglasses are excluded from the scope of this European Standard.
- Corrigendum2 pagesEnglish languagee-Library read for1 day
This European Standard specifies a method for simulating the release of nickel from articles intended to come
into direct and prolonged contact with the skin in order to determine whether such items release nickel at a
rate greater than 0,5 µg/cm2/week.
- Standard16 pagesEnglish languagee-Library read for1 day
This European Standard specifies a method for simulating the release of nickel from articles intended to come
into direct and prolonged contact with the skin in order to determine whether such items release nickel at a
rate greater than 0,5 µg/cm2/week.
- Standard16 pagesEnglish languagee-Library read for1 day
This European Standard specifies a method for accelerated wear and corrosion, to be used prior to the detection of nickel release from coated items that come into direct and prolonged contact with the skin.
- Standard14 pagesEnglish languagee-Library read for1 day
This European Standard specifies a method for accelerated wear and corrosion, to be used prior to the detection of nickel release from coated items that come into direct and prolonged contact with the skin.
- Standard14 pagesEnglish languagee-Library read for1 day
Frequently Asked Questions
An EU Directive is a legislative act of the European Union that sets out goals that all EU member states must achieve. However, it is up to each member state to devise their own laws on how to reach these goals through national transposition. Directives are used to harmonize laws across the EU, particularly for the functioning of the single market.
Directive 2004/96/EC covers "Commission Directive 2004/96/EC amending Council Directive 76/769/EEC as regards restrictions on the marketing and use of nickel for piercing post assemblies for the purpose of adapting its Annex I to technical progress". There are 11 standards associated with this directive.
Harmonized standards under 2004/96/EC are European standards (ENs) developed by CEN, CENELEC, or ETSI in response to a mandate from the European Commission. When these standards are cited in the Official Journal of the European Union, products manufactured in conformity with them benefit from a presumption of conformity with the essential requirements of 2004/96/EC, facilitating CE marking and free movement within the European Economic Area.