Restrictions in marketing and use
EU wide Marketing and Use Restrictions
Until recently, all restrictions on the marketing and use of dangerous chemicals and substances were implemented by the European directive 76/769 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. The use of a number of glycol ethers is restricted through this legal instrument through its transposition into the national laws of member states.
The 16th amendment to directive 76/769 introduced the requirement that any preparations containing category 1 or 2 carcinogenic, mutagenic or reprotoxic (CMR) substances must be marked “Restricted to professional users”. It covered all classified substances in annex one of the Dangerous Substances Directive (67/548) up to and including the 21st adaptation. It was published as directive 97/56 and should have been adopted by all member states by the 1/3/99. Under this amendment, the use of such substances in preparations intended for sale to consumers became prohibited at levels = 0.5% for category 1 and 2 reprotoxic substances. Preparations containing such restricted substances have to be labelled “restricted to professional users”. Point 31 of the directive (the list of such restricted reprotoxic substances) contained the following glycol ethers:
- EGME (ethylene glycol methyl ether)
- EGEE (ethylene glycol ethyl ether) (see note 1)
- EGDME (ethylene glycol dimethyl ether)
- DEGDME (diethylene glycol dimethyl ether)
- TEGDME (triethylene glycol dimethyl ether)
- 1PG2ME (1 propylene glycol 2 methyl ether) (see note 2)
- 1PG2MEA (1 propylene glycol 2 methyl ether) (see note 2)
Note 1: Not produced commercially in the EU
Note 2: No known commercial source of production exists.
For those substances listed above that are produced commercially, industry has in place a charter to make sure that the substances are only sold into compliant applications and uses where strict exposure control measures are in place. For further information please see charter
Following the European risk assessments on the two priority list substance DEGBE and DEGME (carried out under regulation1488/94) the Dutch rapporteur identified that specific measures needed to be implemented for both substances to control risks during certain specific uses. The proposed risk reduction measures were published in Commission decision 1999/721 and proposed options to reduce the risks from use of DEGBE in spray applied paints and DEGME in paint strippers. After lengthy discussions with industry, it was determined that the most effective route to control such risks was through specified restrictions implemented via directive 76/769. These measures were implemented by decision no 1348/2008/EC of the European Parliament and of the Council. The specific measures were:
- That DEGME should not be placed on the market after 27 June 2010, for supply to the general public, as a constituent of paints, paint strippers, cleaning agents, self-shining emulsions or floor sealants in concentrations equal to or greater than 0,1 % by mass
- That DEGBE should not be placed on the market for the first time after 27 June 2010, for supply to the general public, as a constituent of spray paints or spray cleaners in aerosol dispensers in concentrations equal to or greater than 3 % by mass and that existing spray paints and spray cleaners in aerosol dispensers containing = 3% DEGBE should not be sold to the general public after 27 December 2010. Paints containing = 3% DEGBE sold to the general public must by 27 December 2010 as carry the marking “Do not use in paint spraying equipment”.
A point of importance is that directive 76/769 was repealed and replaced by the REACH regulation, with the change becoming effective on 1/6/09. The new legislative instrument for restrictions on the manufacture, placing on the market and use of dangerous substances, preparations and articles in the REACH regulation 1907/2006 and its annex XVII provides that substances, mixtures or articles may not be manufactured, placed on the market or used unless they comply with the conditions of any restrictions laid down in their regard in Annex XVII. When REACH was published, Annex XVII was populated with the contents of Annex I of directive 76/769 as it was at the time. A number of legislative restrictions were still in the process of discussion, including the restrictions on DEGME and DEGBE, which were never actually implemented in directive 76/769. For this reason, REACH was amended with regulation 555/2009 to include all the transitional restrictions into REACH, including the measures for DEGBE and DEGME. The restrictions on the reprotoxic glycol ethers are now covered in Point 30 of appendix 6 of Annex XVIII of REACH.
Some e-series glycol ethers are subject to Annex 17 of the REACH regulation, previously Marketing & Uses Directive, and their usage in some specific applications is either restricted or forbidden.
National Restrictions in France/Restrictions in cosmetics
On 15th December 2005, France introduced restrictions on the use of a small number of glycol ethers in cosmetic products. As required, these measures and their scientific justification were notified to the EU Commission for review. The Scientific Committee on Consumer Products (SCCP – part of DG Health and Consumers) assessed the proposed measures and the evidence behind them and issues their opinions at their 10th and 11th plenary meetings on 19/12/06 and 21/3/07 respectively (references SCCP1043/06, SCCP1044/06 and SCCP1045/06). The SCCP endorsed the French measures as scientifically justified. These restrictions were as follows:
- DEGBE is only permitted to be used in hair dyes up to a maximum concentration of 9% (Please note that this is the only known use in cosmetic products for this substance.)
- DEGEE is only permitted to be used in cosmetic products up to a maximum concentration of 1.5%. This is restricted to topical products only as oral hygiene products are excluded. In addition, DEGEE used must be at least 99.5% pure and contain less than 0.2% ethylene glycol as an impurity.
- EGBE is only permitted as solvent in hair dyes at a maximum concentration of up to 4% in oxidative hair dyes and up to 2% in non-oxidative hair dyes. (Please note that this is the only known use in cosmetic products for this substance.)
At the request of industry following the submission of additional data, the SCCP re-reviewed its decision on DEGEE and agreed that the substance was safe to use at a concentration of up to 7.0% in oxidative hair dye formulations and up to 5.0% in non-oxidative hair dye formulations in addition to its use at concentrations up to 1.5% in all cosmetic products except products for oral hygiene and eye products does not pose a risk to the health of the consumer, provided that the level of ethylene glycol in DEGEE used is < 0.2%. This opinion was decided at the 18th plenary on 16/12/08 and published as opinion SCCP/1200/08.
The restrictions on DEGBE and EGBE have now been implemented in the EU by an amendment to the cosmetics directive 76/768 (amending directive 2009/6) which also includes a restriction prohibiting use in aerosol dispenser sprays, but the restriction on DEGEE has not yet been implemented in the cosmetics directive.