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Document 52023XC0613(01)
Summary of European Commission Decisions on authorisations for the placing on the market for the use and/or for use of substances listed in Annex XIV to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (Published pursuant to Article 64(9) of Regulation (EC) No 1907/2006 (OJ L 396, 30.12.2006, p. 1.)) (Text with EEA relevance) 2023/C 206/05
Summary of European Commission Decisions on authorisations for the placing on the market for the use and/or for use of substances listed in Annex XIV to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (Published pursuant to Article 64(9) of Regulation (EC) No 1907/2006 (OJ L 396, 30.12.2006, p. 1.)) (Text with EEA relevance) 2023/C 206/05
Summary of European Commission Decisions on authorisations for the placing on the market for the use and/or for use of substances listed in Annex XIV to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (Published pursuant to Article 64(9) of Regulation (EC) No 1907/2006 (OJ L 396, 30.12.2006, p. 1.)) (Text with EEA relevance) 2023/C 206/05
C/2023/3517
OJ C 206, 13.6.2023, p. 7–9
(BG, ES, CS, DA, DE, ET, EL, EN, FR, GA, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
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13.6.2023 |
EN |
Official Journal of the European Union |
C 206/7 |
Summary of European Commission Decisions on authorisations for the placing on the market for the use and/or for use of substances listed in Annex XIV to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)
(Published pursuant to Article 64(9) of Regulation (EC) No 1907/2006 (1))
(Text with EEA relevance)
(2023/C 206/05)
Decision granting an authorisation
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Reference of the decision (2) |
Date of decision |
Substance name |
Holder of the authorisation |
Authorisation number |
Authorised use |
Date of expiry of review period |
Reasons for the decision |
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C(2023) 3517 |
6 Jun 2023 |
4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (‘4-tert-OPnEO’) EC No.-; CAS No.- 4-Nonylphenol, branched and linear, ethoxylated (4-NPnEO) EC No.-; CAS No.- |
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REACH/23/17/0 REACH/23/17/1 |
Formulation and filling of buffer solutions containing 4-tert-OPnEO for the manufacturing of and use in in-vitro Diagnostic and Life Sciences kits of the product groups sample preparation, PCR and sequencing |
4 January 2031 |
In accordance with Article 60(4) of Regulation (EC) No 1907/2006, the socio-economic benefits outweigh the risk to human health and the environment from the use of the substance and there are no suitable alternative substances or technologies. |
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REACH/23/17/2 |
Formulation and filling of buffer solutions containing 4-NPnEO for the manufacturing of and use in in-vitro Diagnostic and Life Sciences kits of the product groups sample preparation, PCR and sequencing |
4 January 2031 |
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REACH/23/17/3 |
Industrial use of 4-tert-OPnEO in the purification of biomaterial and blocking of non-specific bindings for the use in in-vitro Diagnostic and Life Sciences kits of the product groups sample preparation, PCR and sequencing |
4 January 2031 |
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REACH/23/17/4 |
Industrial use of 4-NPnEO in the purification of biomaterial and blocking of non-specific bindings for the use in in-vitro Diagnostic and Life Sciences kits of the product groups sample preparation, PCR and sequencing |
4 January 2031 |
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REACH/23/17/5 REACH/23/17/6 REACH/23/17/7 |
Professional downstream use of 4-tert-OPnEO in the purification of biomaterial and blocking of non-specific bindings for the use in in-vitro Diagnostic and Life Sciences kits with regulatory impact of the product groups sample preparation, PCR, sequencing and immunoassay |
4 January 2031 |
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REACH/23/17/8 REACH/23/17/9 |
Professional downstream use of 4-NPnEO in the purification of biomaterial and blocking of non-specific bindings for the use in in-vitro Diagnostic and Life Sciences kits with regulatory impact of the product groups sample preparation, PCR, sequencing |
4 January 2031 |
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REACH/23/17/10 REACH/23/17/11 |
Professional downstream use of 4-tert-OPnEO in the purification of biomaterial and blocking of non-specific bindings for Life Sciences kits without regulatory impact of the product groups sample preparation, PCR and sequencing |
4 January 2026 |
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REACH/23/17/12 REACH/23/17/13 |
Professional downstream use of 4-NPnEO in the purification of biomaterial and blocking of non-specific bindings for Life Sciences kits without regulatory impact of the product groups sample preparation, PCR and sequencing |
4 January 2026 |
(1) OJ L 396, 30.12.2006, p. 1.
(2) The decision is available on the European Commission website at: Authorisation (europa.eu).