do-me/EUR-LEX huggingface dataset:
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) 2021/C 463/16
Date: 2021-11-16
Institutions: Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs, European Commission
Subjects: chemical compound, chemical process, food emulsifier, glass, health control, health risk, market approval, marketing standard, medicinal product, packaging product








C_2021463EN.01001701.xml










16.11.2021   


EN


Official Journal of the European Union


C 463/17






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 463/16)

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) 7884


9 November 2021


4-(1,1,3,3-Tetra methylbutyl)phenol, ethoxylated
(4-tert-OPnEO)
EC No: -, CAS No:-


Vetter Pharma-Fertigung GmbH & Co. KG, Schuetzenstrasse 87, 88212 Ravensburg, Germany


REACH/21/9/0


As emulsifier in the siliconisation of glass containers used as primary packaging for two specific medicinal products (NutropinAq® and Lucentis®) of one pharmaceutical company.


4 January 2026


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.






(1)  OJ L 396, 30.12.2006 , p. 1.

(2)  The decision is available on the European Commission website at: Authorisation (europa.eu)
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) 2021/C 463/14
Date: 2021-11-16
Institutions: Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs, European Commission
Subjects: chemical compound, chemical product, health control, health risk, market approval, marketing standard, medical device, medical diagnosis, pharmaceutical product








C_2021463EN.01001501.xml










16.11.2021   


EN


Official Journal of the European Union


C 463/15






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 463/14)

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) 7876


9 November 2021


4-(1,1,3,3-Tetra methylbutyl)phenol, ethoxylated
(4-tert-OPnEO)
EC No: -, CAS No:-


Abbott Diagnostics GmbH, Max Planck Ring 2, D-65205 Delkenheim, Germany


REACH/21/10/0


Professional use as a surfactant, in wash buffer components used in conjunction with Fluorescence In Situ Hybridisation (FISH) test kits and/or their Laboratory Developed Test (LDT) equivalents in clinical diagnostic use for medical analysis of human tissue and blood samples to identify characteristic genetic abnormalities related to specific disease conditions


4 January 2028


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.






(1)  OJ L 396, 30.12.2006 , p. 1.

(2)  The decision is available on the European Commission website at: Authorisation (europa.eu)
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) 2021/C 463/15
Date: 2021-11-16
Institutions: Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs, European Commission
Subjects: chemical compound, chemical product, health control, health risk, market approval, marketing standard, pharmaceutical industry








C_2021463EN.01001601.xml










16.11.2021   


EN


Official Journal of the European Union


C 463/16






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 463/15)

Decision granting an authorisation













Reference of the decision (2)



Date of decision


Substance name


Holders of the authorisation


Authorisation number


Authorised use


Date of expiry
of review period


Reasons for the decision




C(2021) 7877


9 November 2021


4-(1,1,3,3-Tetra methylbutyl)phenol, ethoxylated
(4-tert-OPnEO)
EC No: -, CAS No:-


Boehringer Ingelheim Pharma GmbH & Co. KG, Binger Strasse 173, 55216, Ingelheim am Rhein, Germany;


REACH/21/7/0


In a washing buffer to purify biological APIs (active pharmaceutical ingredients) during the production of Palivizumab and Moxetumomab pasudotox-tdfk


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.




Boehringer Ingelheim RCV GmbH & Co KG, Dr.-Boehringer-Gasse 5-11, 1121 Wien, Austria.


REACH/21/7/1






(1)  OJ L 396, 30.12.2006 , p. 1.

(2)  The decision is available on the European Commission website at: Authorisation (europa.eu)
Non-opposition to a notified concentration (Case M.10474 – NESTE / RAVAGO / JV) (Text with EEA relevance) 2021/C 480/04
Date: 2021-11-16
Institutions: Directorate-General for Competition, European Commission
Subjects: economic concentration, merger control, oil refining, plastic waste, plastics industry








C_2021480EN.01000401.xml










29.11.2021   


EN


Official Journal of the European Union


C 480/4






Non-opposition to a notified concentration
(Case M.10474 – NESTE / RAVAGO / JV)
(Text with EEA relevance)
(2021/C 480/04)
On 16 November 2021, the Commission decided not to oppose the above notified concentration and to declare it compatible with the internal market. This decision is based on Article 6(1)(b) of Council Regulation (EC) No 139/2004 (1). The full text of the decision is available only in English and will be made public after it is cleared of any business secrets it may contain. It will be available:






—


in the merger section of the ‘Competition policy’ website of the Commission (http://ec.europa.eu/competition/mergers/cases/). This website provides various facilities to help locate individual merger decisions, including company, case number, date and sectoral indexes,










—


in electronic form on the EUR-Lex website (http://eur-lex.europa.eu/homepage.html?locale=en) under document number 32021M10474. EUR-Lex is the online point of access to European Union law.






(1)  OJ L 24, 29.1.2004, p. 1.
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) 2021/C 463/17
Date: 2021-11-16
Institutions: Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs, European Commission
Subjects: chemical compound, chemical product, health control, health risk, market approval, marketing standard, pharmaceutical industry








C_2021463EN.01001801.xml










16.11.2021   


EN


Official Journal of the European Union


C 463/18






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






(1)  OJ L 396, 30.12.2006 , p. 1.

(2)  The decision is available on the European Commission website at: Authorisation (europa.eu)
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) 2021/C 463/12
Date: 2021-11-16
Institutions: Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs, European Commission
Subjects: chemical compound, chemical process, chemical product, food emulsifier, glass, health control, health risk, market approval, marketing standard, medicinal product, packaging product








C_2021463EN.01001301.xml










16.11.2021   


EN


Official Journal of the European Union


C 463/13






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 463/12)

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) 7875


9 November 2021


4-(1,1,3,3-Tetra methylbutyl)phenol, ethoxylated (4-tert-OPnEO) EC No: -, CAS No:-


Nuova Ompi S.r.l. Unipersonale, Via Molinella 17, 35017 Piombino Dese (PD), Italy


REACH/21/8/0


As emulsifier in the siliconisation of glass containers used as primary packaging for one specific medicinal product NeoRecormon® of one pharmaceutical company


4 January 2026


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.






(1)  OJ L 396, 30.12.2006 , p. 1.

(2)  The decision is available on the European Commission website at: Authorisation (europa.eu)
Non-opposition to a notified concentration (Case M.10474 – NESTE / RAVAGO / JV) (Text with EEA relevance) 2021/C 475/02
Date: 2021-11-16
Institutions: Directorate-General for Competition, European Commission
Subjects: economic concentration, merger control, oil refining, plastic waste, plastics industry








C_2021475EN.01000201.xml










25.11.2021   


EN


Official Journal of the European Union


C 475/2






Non-opposition to a notified concentration
(Case M.10474 – NESTE / RAVAGO / JV)
(Text with EEA relevance)
(2021/C 475/02)
On 16 November 2021, the Commission decided not to oppose the above notified concentration and to declare it compatible with the internal market. This decision is based on Article 6(1)(b) of Council Regulation (EC) No 139/2004 (1). The full text of the decision is available only in English and will be made public after it is cleared of any business secrets it may contain. It will be available:






—


in the merger section of the ‘Competition policy’ website of the Commission (http://ec.europa.eu/competition/mergers/cases/). This website provides various facilities to help locate individual merger decisions, including company, case number, date and sectoral indexes,










—


in electronic form on the EUR-Lex website (http://eur-lex.europa.eu/homepage.html?locale=en) under document number 32021M10474. EUR-Lex is the online point of access to European Union law.






(1)  OJ L 24, 29.1.2004, p. 1.
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) 2021/C 463/13
Date: 2021-11-16
Institutions: Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs, European Commission
Subjects: biochemistry, chemical compound, chemical product, health control, health risk, market approval, marketing standard, vaccination, vaccine








C_2021463EN.01001401.xml










16.11.2021   


EN


Official Journal of the European Union


C 463/14






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 463/13)

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) 7874


9 November 2021


4-(1,1,3,3-Tetra methylbutyl)phenol, ethoxylated
(4-tert-OPnEO)
EC No: -, CAS No:-


Janssen Vaccines & Prevention B.V., Archimedesweg 4, 2333 CN Leiden, Netherlands


REACH/21/4/0


Lysing agent for the permeabilisation of the host cell membrane to release adenovirus particles used for the manufacture of vaccines, allowing the selective elimination of enveloped adventitious viruses, compatible with the chemicals needed to control the host cell DNA precipitation in the next process step


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.




Janssen Biologics B.V. Einsteinweg 101, 2333 CB Leiden, Netherlands


REACH/21/4/1






(1)  OJ L 396, 30.12.2006 , p. 1.

(2)  The decision is available on the European Commission website at: Authorisation (europa.eu)
Non-opposition to a notified concentration (Case M.10501 – BOUYGUES / DESTIA) (Text with EEA relevance) 2021/C 472/02
Date: 2021-11-16
Institutions: Directorate-General for Competition, European Commission
Subjects: building industry, economic concentration, means of communication, merger control, rail transport, road network, telecommunications, town planning, transport infrastructure








C_2021472EN.01000201.xml










23.11.2021   


EN


Official Journal of the European Union


C 472/2






Non-opposition to a notified concentration
(Case M.10501 – BOUYGUES / DESTIA)
(Text with EEA relevance)
(2021/C 472/02)
On 16 November 2021, the Commission decided not to oppose the above notified concentration and to declare it compatible with the internal market. This decision is based on Article 6(1)(b) of Council Regulation (EC) No 139/2004 (1). The full text of the decision is available only in English and will be made public after it is cleared of any business secrets it may contain. It will be available:






—


in the merger section of the ‘Competition policy’ website of the Commission (http://ec.europa.eu/competition/mergers/cases/). This website provides various facilities to help locate individual merger decisions, including company, case number, date and sectoral indexes,










—


in electronic form on the EUR-Lex website (http://eur-lex.europa.eu/homepage.html?locale=en) under document number 32021M10501. EUR-Lex is the online point of access to European Union law.






(1)  OJ L 24, 29.1.2004, p. 1.
Commission Implementing Regulation (EU) 2021/2035 of 16 November 2021 entering a name in the register of protected designations of origin and protected geographical indications (‘Alho da Graciosa’ (PGI))
Date: 2021-11-16
Institutions: Directorate-General for Agriculture and Rural Development, European Commission
Subjects: Azores, Portugal, bulb vegetable, designation of origin, dried product, labelling, product designation








L_2021416EN.01000101.xml










23.11.2021   


EN


Official Journal of the European Union


L 416/1








            COMMISSION IMPLEMENTING REGULATION (EU) 2021/2035
of 16 November 2021
         
entering a name in the register of protected designations of origin and protected geographical indications (‘Alho da Graciosa’ (PGI))


THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,


Having regard to Regulation (EU) No 1151/2012 of the European Parliament and of the Council of 21 November 2012 on quality schemes for agricultural products and foodstuffs (1), and in particular Article 52(2) thereof,

Whereas:







(1)


Pursuant to Article 50(2)(a) of Regulation (EU) No 1151/2012, Portugal’s application to register the name ‘Alho da Graciosa’ was published in the Official Journal of the European Union (2).












(2)


As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the name ‘Alho da Graciosa’ should therefore be entered in the register,





HAS ADOPTED THIS REGULATION:



Article 1
The name ‘Alho da Graciosa’ (PGI) is hereby entered in the register.
The name specified in the first paragraph denotes a product in Class 1.6. – Fruit, vegetables and cereals, fresh or processed, as listed in Annex XI to Commission Implementing Regulation (EU) No 668/2014 (3).


Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.




This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 16 November 2021.


For the Commission,


On behalf of the President,

Janusz WOJCIECHOWSKI
            

Member of the Commission






(1)  
            OJ L 343, 14.12.2012, p. 1.

(2)  
            OJ C 311, 3.8.2021, p. 24.

(3)  Commission Implementing Regulation (EU) No 668/2014 of 13 June 2014 laying down rules for the application of Regulation (EU) No 1151/2012 of the European Parliament and of the Council on quality schemes for agricultural products and foodstuffs (OJ L 179, 19.6.2014, p. 36).
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) 2021/C 463/11
Date: 2021-11-16
Institutions: Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs, European Commission
Subjects: chemical compound, chemical product, health control, health risk, market approval, marketing standard, medical device, medical diagnosis








C_2021463EN.01001201.xml










16.11.2021   


EN


Official Journal of the European Union


C 463/12






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 463/11)

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) 7883


9 November 2021


4-(1,1,3,3-Tetra methylbutyl)phenol, ethoxylated
(4-tert-OPnEO)
EC No: -, CAS No:-


Ortho-Clinical Diagnostics France, 8 Rue Rouget de l’Isle, 92130 Issy-les-Moulineaux, France


REACH/21/6/0


As Triton X-100 in two in vitro diagnostic VITROS® products used by professional diagnostic laboratories to detect antibodies to human hepatitis A virus and IgG antibodies to rubella virus


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.






(1)  OJ L 396, 30.12.2006 , p. 1.

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