Restrictions on marketing and use
The legislative instrument for restrictions on the manufacture, placing on the market and use of certain dangerous substances, mixtures and articles is the REACH regulation (EC) No 1907/2006 and its Title VIII and Annex XVII. 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. Annex XVII came into force on 1 June 2009.
Certain Glycol Ethers are included in Annex XVII (1), namely 2-(2-methoxyethoxy)ethanol (DEGME) (Point 54) and 2-(2-butoxyethoxy) ethanol (DEGBE) (Point 55)
(1) Commission Regulation (EC) No 552/2009 of 22 June 2009
CAS No 111-77-3; EC No 203-906-6
|Shall 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 weight.|
CAS No 112-34-5; EC No 203-961-6
Following the European risk assessments on DEGBE and DEGME specific measures needed to be implemented for both substances to limit the risks in certain specific uses. The proposed risk reduction measures were published in Commission Recommendation 1999/721/EC and proposed options to reduce the risks from use of DEGBE in spray applied paints and DEGME in paint strippers.
The list of restrictions, Annex XVII to REACH, restricts also carcinogenic, mutagenic, or reprotoxic (CMR) substances (Entry 28, 29, and 30)
Specific Glycol Ethers are listed in Appendix 6 of Annex XVII related to Entry 30:
Entry 30 outlines the use restrictions for substances which are classified as toxic to reproduction category 1A or 1B or toxic to reproduction category 1 or 2:
|30. Substances which appear in Part 3 of Annex VI to Regulation (EC) No 1272/2008 classified as toxic to reproduction category 1A or 1B (Table 3.1) or toxic to reproduction category 1 or 2 (Table 3.2) and listed as follows:|
Reproductive toxicant category 1A adverse effects on sexual function and fertility or on development (Table 3.1) or reproductive toxicant category 1 with R60 (May impair fertility) or R61 (May cause harm to the unborn child) (Table 3.2) listed in Appendix 5
Reproductive toxicant category 1B adverse effects on sexual function and fertility or on development (Table 3.1) or reproductive toxicant category 2 with R60 (May impair fertility) or R61 (May cause harm to the unborn child) (Table 3.2) listed in Appendix 6
|“… the following shall apply to entries 28 to 30:|
1. Shall not be placed on the market, or used,
for supply to the general public when the individual concentration in the substance or mixture is equal to or greater than:
Without prejudice to the implementation of other Community provisions relating to the classification, packaging and labelling of substances and mixtures, suppliers shall ensure before the placing on the market that the packaging of such substances and mixtures is marked visibly, legibly and indelibly as follows: ‘Restricted to professional users’.
2. By way of derogation, paragraph 1 shall not apply to:
a. medicinal or veterinary products as defined by Directive 2001/82/EC and Directive 2001/83/ EC;
b. cosmetic products as defined by Directive 76/ 768/EEC;
c. the following fuels and oil products:
d. artists’ paints covered by Directive 1999/45/ EC;
e. the substances listed in Appendix 11, column 1, for the applications or uses listed in Appendix 11, column 2. Where a date is specified in column 2 of Appendix 11, the derogation shall apply until the said date.
Glycol Ethers listed in Appendix 6 (see below) are either used as intermediates under strictly controlled conditions, not commercially available or are trace impurities.
|Substances||Index N°||EC N°||CAS N°|
|2-Methoxyethanol; ethylene glycol monomethyl ether; methylglycol (EGME, Note 1)||603-011-00-4||203-713-7||109-86-4|
|2-Ethoxyethanol; ethylene glycol monoethyl ether; ethylglycol (EGEE; Note 1)||603-012-00-X||203-804-1||110-80-5|
|2-Methoxypropanol (1PG2ME; Note 2)||603-106-00-0||216-455-5||216-455-5|
|2-Methoxypropyl acetate (1PG2MEA; Note 2)||607-251-00-0||274-724-2||274-724-2|
|2-Methoxyethyl acetate; ethylene glycol monomethyl ether acetate; methylglycol acetate (EGMEA)||607-036-00-1||203-772-9||203-772-9|
|2-Ethoxyethyl acetate; ethylene glycol monoethyl ether acetate; ethylglycol acetate (EGEEA)||607-037-00-7||203-839-2||203-839-2|
Italicized text not contained in the regulatory text. Note 1: Not commercially sold and available in the EU from OSPA member companies. 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.
Latest update: 23 March 2017. Refer to ECHA for current or in progress restrictions and authorizations.