Regulatory aspects

Authorisation and Restriction

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.
Certain Glycol Ethers are included in Annex XVII namely 2-(2-methoxyethoxy)ethanol (DEGME), reprotox 1B since 2021, previously reprotox 2 (entry 54) and 2-(2-butoxyethoxy) ethanol (DEGBE), eye irritation (entry 55).

2-(2-methoxyethoxy)ethanol (DEGME)
CAS No 111-77-3; EC No 203-906-6
  1. 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.
2-(2-butoxyethoxy)ethanol (DEGBE)
CAS No 112-34-5; EC No 203-961-6
  1. Shall 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 weight.
  2. Spray paints and spray cleaners in aerosol dispensers containing DEGBE and not conforming to paragraph 1 shall not be placed on the market for supply to the general public after 27 December 2010.
  3. Without prejudice to other Community legislation concerning the classification, packaging and labelling of substances and mixtures, suppliers shall ensure before the placing on the market that paints other than spray paints containing DEGBE in concentrations equal to or greater than 3 % by weight of that are placed on the market for supply to the general public are visibly, legibly and indelibly marked by 27 December 2010 as follows: “Do not use in paint spraying equipment”.

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 reprotoxic substances 1A&B in consumer products (entry 30). Whereas several glycol ethers are part of the appendix 6 due to the OSPA charter, none is sold or used by consumers as all glycol ethers with reprotox 1B classification are either used as intermediates under controlled conditions, not commercially available or are trace impurities.

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,

  • as substances,
  • as constituents of other substances, or,
  • in mixtures,

for supply to the general public when the individual concentration in the substance or mixture is equal to or greater than:

  • either the relevant specific concentration limit specified in Part 3 of Annex VI to Regulation (EC) No 1272/2008, or,
  • the relevant concentration specified in Directive 1999/45/EC where no specific concentration limit is set out in Part 3 of Annex VI to Regulation (EC) No 1272/2008.

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:

  1. motor fuels which are covered by Directive 98/70/EC,
  2. mineral oil products intended for use as fuel in mobile or fixed combustion plants,
  3. fuels sold in closed systems (e.g. liquid gas bottles);

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.

Authorisation

Substances meeting the criteria for classification as carcinogenic, mutagenic or toxic for reproduction (CMR) category 1A or 1B in accordance with the CLP Regulation are usually identified as Substances of Very High Concern. Only DEGME having received the 1B classification in 2021 is currently not a SVHC.

Abbreviation Substance name EC number CAS number SVHC since
EGME 2-methoxyethanol 203-713-7 109-86-4 December 2010, part 9th prioritization list October 2019, but not included in Annex XIV -December 2021
EGMEA 2-methoxyethyl acetate 203-772-9 110-49-6 July 2019
DEGME 2-(2-methoxyethoxy)ethanol 203-906-6 111-77-3 Not yet started
EGDME 1,2-dimethoxyethane 203-794-9 110-71-4 June 2016
DEGDME bis(2-methoxyethyl) ether, diglyme 203-924-4 111-96-6 December 2016, part of 4th prioritization list January 2013, included into Annex XIV
TEGDME 1,2-bis(2-methoxyethoxy)ethane 203-977-3 112-49-2 June 2016
TetraEGDME Bis(2-(2-methoxyethoxy)ethyl) ether 205-594-7 143-24-8 January 2021
EGEE 2-ethoxyethanol 203-804-1 110-80-5 December 2010, part 9th prioritization list October 2019, but not included in Annex XIV -December 2021
EGEEA 2-ethoxyethyl acetate 203-839-2 111-15-9 June 2011
EGDEE 1,2-dioxyethane 211-076-1 629-14-1 December 2012
1PG2ME 2-methoxy-1-propanol 216-455-5 1589-47-5 No REACH registration, no action recorded
1PG2MEA 2-methoxypropyl acetate 274-724-2 70657-70-4 No REACH registration, no action recorded

Latest update: March 2022. Refer to ECHA for current or in progress restrictions and authorizations.