Marketing and use of certain dangerous substances and preparations

In order to protect the general public and the environment from certain dangerous substances and preparations and to ensure the proper functioning of the internal market, the European Union (EU) has drawn up a list of substances and preparations to which restrictions on marketing and use apply. The Directive is revoked and replaced as of 31 May 2009 by the REACH Regulation, adopted at the end of 2006.

ACT

Council Directive 76/769/EEC of 27 July 1976 on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations [See amending acts].

SUMMARY

For the purposes of this Directive:

• "substance" means the chemical element in its natural state or as produced by the industry;
• "preparation" means the mixtures or solutions consisting of two or more substances.

The Directive is not applicable to:

• the transport of dangerous substances and preparations by rail, road, waterway, sea or air;
• dangerous substances and preparations exported to third countries;
• substances and preparations in transit which are under customs supervision, provided that they do not undergo any form of processing.

The limits laid down in the Directive are not applicable to products marketed or used for research and development or analysis purposes.

The Annex contains the list of products covered by the measures provided for in this Directive as well as the conditions governing their placing on the market. Further substances and preparations are given in the Directives listed below.

Amendments to Annex I (list of substances and preparations):

Tris phosphate [2,3 dibromopropyl] [Directive 79/663/EEC]

Restrictions on the use of the substance Tris [2,3-dibromopropyl] phosphate.

Benzene [Directive 82/806/EEC]

Ban on the use of benzene in toys placed on the market when the concentration of free form benzene exceeds 5mg/kg of the weight of the toy or of part of the toy.

Polychlorinated terphenyls (PCT) [Directive 82/828/EEC ]

Authorisation of the use, until the end of 1984, of re-usable thermoplastic machining materials containing not more than 50% of PCT and intended for securing, assembling and immobilising components in order to facilitate their precision machining and shaping in the manufacture or maintenance of gas turbines. This authorisation was granted without prejudice to other Directives limiting the use of PCT and the overall objective of reducing the use of this substance.

Tris-aziridinyl phosphinoxide, polybrominated biphenyl (PBB), 3,3'-dimethoxybenzidine, ammonium polysulphides and volatile esters of bromoacetic acid [Directive 83/264/EEC ]

Ban on the use of:

• Tris-aziridinyl phosphinoxide and polybrominated biphenyl in products intended to come into contact with the skin;
• 3,3'-dimethoxybenzidine, ammonium polysulphides and volatile esters of bromoacetic acid in jokes or novelties on account of their harmful effects, especially on children.

Asbestos fibres [Directive 83/478/EEC ]

Ban on the marketing and use of asbestos fibres; crocidolite, chrysotile, amosite, anthophyllite, actinolite and tremolite, and products containing these substances.

Polychlorinated biphenyls (PCBs)/polychlorinated terphenyls (PCTs) [Directive 85/467/EEC]

Ban on the use and marketing of PCBs and PCTs.

Asbestos [Directive 85/610/EEC ]

Ban on the marketing and use of asbestos in the following:

• toys;
• materials or preparations intended to be applied by spraying;
• finished products in powder form;
• smoking accessories;
• catalytic filters and insulation devices intended for, or incorporated in, heaters using liquefied gas;
• paints and varnishes.

Carcinogens, lead carbonates and sulphates, mercury compounds, arsenic compounds and organostannic compounds [Directives 89/677/EEC and 2006/139/EC]

Restrictions on the marketing and use of a number of substances or families of chemical substances, particularly the following:

• five carcinogens, the marketing of which is strictly controlled;
• lead carbonates and sulphates, the use of which is prohibited in paint;
• mercury compounds, arsenic compounds and organostannic compounds which may no longer be used as such or as constituents of preparations used for the protection of the hulls of boats or of any totally or partially submerged appliances or equipment.

Pentachlorophenol and its compounds [Directive 91/173/EEC ]

Ban on the use of pentachlorophenol and its compounds in a concentration equal to or greater than 0.1% by mass, except in substances and preparations intended for use in industrial installations:

• in the treatment of wood;
• in the impregnation of heavy-duty textiles;
• as a synthesising and/or processing agent in industrial processes.

Cadmium [Directive 91/338/EEC ]

This Directive prohibits the use of cadmium and its compounds in three areas: pigments, stabilisers and surface treatment. Furthermore, it provides for a general exemption clause where justification exists on the grounds of safety or reliability and where the use of cadmium is unavoidable. It should be noted that, in order to take account of advances in technical know-how, the Council decided to reassess the situation within three years of the date of adoption of the Directive.

Ugilec 141, Ugilec 121, DBBT [Directive 91/339/EEC ]

Ban on the use of the following substances:

• Ugilec, 141 except in plant or machinery already in service and for use in their maintenance until such time as the plant or machinery are disposed of or reach the end of their expected service life;
• Ugilec 121 and DBBT.

Nickel [Directive 94/27/EC ]

Restrictions on the use of nickel in jewellery and personal objects coming into contact with the skin.

Flammable substances [Directive 94/48/EC ]

This Directive lists the flammable substances, the use of which is prohibited, especially in aerosol generators intended for entertainment and decorative purposes.

Creosote, chlorinated solvents, and carcinogenic, mutagenic and teratogenic substances and preparations [Directive 94/60/EC ]

Restrictions on the use of the abovementioned products on account of their harmful, and in particular carcinogenic, effects.

Hexachloroethane [Directive 97/16/EC ]

Ban on the use of hexachloroethane in the manufacture or processing of non-ferrous metals, apart from some exceptions:

• in non-integrated aluminium foundries producing specialised casts for uses requiring high safety and quality standards and where the average daily consumption rate is less than 1.5 kg of hexachloroethane;
• for the purposes of grain refinement in the production of AZ 81, AZ 91 and AZ 92 magnesium alloys.

Substances classified as carcinogenic, mutagenic or toxic to reproduction - CMR [Directives 97/56/EC , 1999/43/EC, 2001/41/EC, 2003/34/EC, 2003/36/EC, 2005/90/EC]

Ban on the marketing to the general public of substances classified as carcinogenic, mutagenic or toxic to reproduction, and of preparations containing these substances.

Directive 2005/90/EC adds to the list in Directive 76/769/EEC 346 entries concerning substances newly classified or reclassified as potentially causing cancer, heritable genetic damage or birth defects, or impairing fertility.

Batteries and accumulators containing mercury, cadmium and lead [Directive 91/157/EC ]

Restrictions and ban on the marketing of certain batteries and accumulators containing the above mentioned dangerous substances. In addition, the Directive also approximates the existing laws of the Member States with a view to finalising the recovery and controlled disposal of batteries and accumulators containing dangerous substances.

Short-chain chlorinated paraffins (SCCPs) [Directive 2002/45/EC ]

Ban on the use and marketing of substances or preparations containing more than 1% SCCPs in metalworking and leather finishing. By 1 January 2003 all remaining uses of SCCPs were to undergo a risk-assessment review.

Azoic colouring agents [Directive 2002/61/EC ]

Ban on the use of dangerous azocolourants and the placing on the market of some textiles and leather articles coloured with such substances and coming into contact with the skin, owing to the cancer risks. In the case of textile articles made of recycled fibres, the maximum concentration level applicable to the amines listed in point 43 of the appendix to Directive 76/769/EEC must not exceed 70 ppm. This limit applied as a transitional measure until 1 January 2005 if the amines in question were released by residues deriving from previous dyeing of the same fibres.

Pentabromodiphenyl ether (pentaBDE), octabromodiphenyl ether (octaBDE) [Directive 2003/11/EC]

Ban on the marketing and use of pentaBDE and octaBDE and on the marketing of articles containing concentrations in excess of 0.1 % by mass of pentaBDE and octaBDE.

Nonylphenol, nonylphenol ethoxylate and cement [Directive 2003/53/EC ]

Harmonisation of the provisions on the marketing and use of nonylphenol, nonylphenol ethoxylate and cement (dangerous substances used in the production of resins, plastics, stabilisers in the polymer industry, in the manufacture of phenolic oximes, and in some speciality paints).

Toluene and trichlorobenzene [Directive 2005/59/EC ]

This Directive sets a threshold of 0.1% by mass in adhesives and spray paints intended for sale to the general public (toluene) and 0.1% by mass for all uses except as an intermediate (trichlorobenzene).

Certain polycyclic aromatic hydrocarbons in extender oils and tyres [Directive 2005/69/EC ]

This Directive is intended to restrict the marketing and use of extender oils rich in polycyclic aromatic hydrocarbons (PAHs), thus limiting the production of tyres made from these oils and tyre debris containing carcinogens. The objective is to control the possible risks to health and the environment.

RELATED ACTS

Proposal for a Decision of the European Parliament and of the Council amending Council Directive 76/769/EEC as regards restrictions on the marketing and use of certain dangerous substances and preparations (Dichloromethane) [COM(2008) 80 final - Not published in the Official Journal].

Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC [Official Journal L 396 of 30.12.2006].

The EU modernises European legislation on chemical substances and establishes a single, integrated system for registering, evaluating and authorising chemical substances (REACH). Its aim is to improve the protection of both human health and the environment while ensuring competitiveness and strengthening the innovative spirit of the European chemical industry. A European Chemicals Agency is also established which is responsible for dealing with day-to-day tasks relating to REACH.

This Regulation repeals Directive 76/769/EC as of 31 May 2009.

Directive 2005/84/EC of the European Parliament and of the Council of 14 December 2005 amending for the 22nd time Council Directive 76/769/EEC on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations (phthalates in toys and childcare articles). Corrected by: Addendum [Official Journal L 344 of 27.12.2005].

This Directive prohibits:

• the use of certain phthalates in toys and childcare products intended to be placed in the mouth by children under three years of age;
• the marketing of products containing certain phthalates, while at the same time imposing an obligation to affix a warning notice to soft PVC toys intended for children under three years of age and likely to be placed in the mouth. According to the Addendum to this Directive, the Commission is to prepare a guidance document setting out the conditions under which certain phthalates may be present in childcare articles which may be placed in the mouth by children under the age of three.

These measures will be reviewed in 2010 at the latest.

It should be noted that this Directive also amends Council Directive 88/378/EEC on the approximation of the laws of the Member States concerning toy safety and Commission Decision 1999/815/EC, which is further extended, prohibiting the placing on the market of toys and childcare articles intended to be placed in the mouth by children under three years of age and made of soft PVC containing certain phthalates.

Last updated: 15.05.2008