# C_2022420EN.01000701.xml

| 3.11.2022 | EN | Official Journal of the European Union | C 420/7 |
| --- | --- | --- | --- |

3.11.2022

EN

Official Journal of the European Union

C 420/7

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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)

(2022/C 420/06)

Decision granting an authorisation

| Reference of the decision (2) | Date of decision | Substance name | Holder(s) of the authorisation | Authorisation number | Authorised use | Date of expiry of review period | Reasons for the decision |
| --- | --- | --- | --- | --- | --- | --- | --- |
| C(2022) 7512 | 27 October 2022 | 4-(1,1,3,3-Tetra methylbutyl)phenol, ethoxylated
  (4-tert-OPnEO)
  EC No: -, CAS No:- | Zoetis Belgium S.A., Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgium | REACH/22/41/0 | Industrial use as a surfactant in a lysis buffer for the release of proteins and antigens from biological material used in the manufacture of three SERELISA veterinary in vitro diagnostic devices for detecting infectious disease in farm animals | 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 uses of the substance and there are no suitable alternative substances or technologies. |
| Delpharm Biotech, 2 Rue Alexander Fleming, 69366 Lyon, France | REACH/22/41/1 |
| Zoetis Belgium S.A. | REACH/22/41/2 | Industrial use in formulation of kits, kit reagents and buffer solutions in two WITNESS and three SERELISA veterinary in vitro diagnostic devices used for detecting certain diseases in pets and farm animals |
| Delpharm Biotech | REACH/22/41/3 |
| Zoetis Belgium S.A. | REACH/22/41/4 | Professional use as a surfactant in kits, kit reagents and buffer solutions in 18 veterinary in vitro diagnostic devices including one SERELISA, six ProFLOK, six WITNESS and five VetScan, in diagnostic laboratories and veterinary clinics for detecting certain diseases in pets and farm animals | 4 January 2033 |
| REACH/22/41/5 | Industrial use as a viral inactivating agent in the manufacture of two veterinary biologic drugs for treatment of osteoarthritis in cats and dogs |

Reference of the decision (2)

Date of decision

Substance name

Holder(s) of the authorisation

Authorisation number

Authorised use

Date of expiry of review period

Reasons for the decision

C(2022) 7512

27 October 2022

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

(4-tert-OPnEO)

EC No: -, CAS No:-

Zoetis Belgium S.A., Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgium

REACH/22/41/0

Industrial use as a surfactant in a lysis buffer for the release of proteins and antigens from biological material used in the manufacture of three SERELISA veterinary in vitro diagnostic devices for detecting infectious disease in farm animals

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

Delpharm Biotech, 2 Rue Alexander Fleming, 69366 Lyon, France

REACH/22/41/1

Zoetis Belgium S.A.

REACH/22/41/2

Industrial use in formulation of kits, kit reagents and buffer solutions in two WITNESS and three SERELISA veterinary in vitro diagnostic devices used for detecting certain diseases in pets and farm animals

Delpharm Biotech

REACH/22/41/3

Zoetis Belgium S.A.

REACH/22/41/4

Professional use as a surfactant in kits, kit reagents and buffer solutions in 18 veterinary in vitro diagnostic devices including one SERELISA, six ProFLOK, six WITNESS and five VetScan, in diagnostic laboratories and veterinary clinics for detecting certain diseases in pets and farm animals

4 January 2033

REACH/22/41/5

Industrial use as a viral inactivating agent in the manufacture of two veterinary biologic drugs for treatment of osteoarthritis in cats and dogs

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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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