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).
CAS No 111-77-3; EC No 203-906-6
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 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,
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.
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|
|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|
|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|
|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|