# C_2021463EN.01001801.xml

| 16.11.2021 | EN | Official Journal of the European Union | C 463/18 |
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16.11.2021

EN

Official Journal of the European Union

C 463/18

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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)

(2021/C 463/17)

Decision granting an authorisation

| 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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| C(2021) 7881 | 9 November 2021 | 4-(1,1,3,3-Tetra methylbutyl)phenol, ethoxylated
  (4-tert-OPnEO)
  EC No: -, CAS No:- | BioMarin International Limited, Shanbally P43 R298, Ringaskiddy, Cork, Ireland | REACH/21/5/0 | Industrial use as a surfactant to perform viral inactivation of biological proteins in the manufacture of a biopharmaceutical Final Bulk Drug Substance (FBDS) for an Enzyme Replacement Therapy (BMN250) for the treatment of Mucopolysaccharidosis IIIB (MPS IIIB) | 4 January 2033 | 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 uses of the substance and there are no suitable alternative substances or technologies. |
| REACH/21/5/1 | Industrial use as a surfactant to perform viral inactivation of biological proteins in the manufacture of a biopharmaceutical Final Bulk Drug Substance (FBDS) for Gene Therapy products for the treatment of rare conditions in the human population |

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

C(2021) 7881

9 November 2021

4-(1,1,3,3-Tetra methylbutyl)phenol, ethoxylated

(4-tert-OPnEO)

EC No: -, CAS No:-

BioMarin International Limited, Shanbally P43 R298, Ringaskiddy, Cork, Ireland

REACH/21/5/0

Industrial use as a surfactant to perform viral inactivation of biological proteins in the manufacture of a biopharmaceutical Final Bulk Drug Substance (FBDS) for an Enzyme Replacement Therapy (BMN250) for the treatment of Mucopolysaccharidosis IIIB (MPS IIIB)

4 January 2033

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 uses of the substance and there are no suitable alternative substances or technologies.

REACH/21/5/1

Industrial use as a surfactant to perform viral inactivation of biological proteins in the manufacture of a biopharmaceutical Final Bulk Drug Substance (FBDS) for Gene Therapy products for the treatment of rare conditions in the human population

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(1)  OJ L 396, 30.12.2006 , p. 1.

(2)  The decision is available on the European Commission website at: Authorisation (europa.eu)

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