Commission Implementing Decision (EU) 2021/2184 of 6 December 2021 concerning the extension of the actions taken by the Health and Safety Executive of the United Kingdom permitting the making available on the market and use of five biocidal products for hand disinfection in accordance with Article 55(1) of Regulation (EU) No 528/2012 of the European Parliament and of the Council (notified under document C(2021) 8729) (Only the English text is authentic)
Date: 2021-12-06
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: United Kingdom, biocide, chemical product, coronavirus disease, decontamination, epidemic, market approval, pharmaceutical product, public health








L_2021444EN.01010501.xml










10.12.2021   


EN


Official Journal of the European Union


L 444/105








            COMMISSION IMPLEMENTING DECISION (EU) 2021/2184
of 6 December 2021
         
concerning the extension of the actions taken by the Health and Safety Executive of the United Kingdom permitting the making available on the market and use of five biocidal products for hand disinfection in accordance with Article 55(1) of Regulation (EU) No 528/2012 of the European Parliament and of the Council


(notified under document C(2021) 8729)


(Only the English text is authentic)


THE EUROPEAN COMMISSION,

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


Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular Article 55(1), third subparagraph, thereof, in conjunction with Article 5(4) of the Protocol on Ireland/Northern Ireland to the Agreement on the Withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community,

Whereas:







(1)


On 11 March 2021, the Health and Safety Executive of the United Kingdom acting on behalf of the Health and Safety Executive for Northern Ireland (‘the UK competent authority’) adopted a decision in accordance with Article 55(1), first subparagraph, of Regulation (EU) No 528/2012, to permit the making available on the market and use in Northern Ireland of the hand disinfection products Cornells Wellness Instant Hand Sanitizer Gel, Cornells Wellness Sports Sanitizer Spray Power Up, Cornells Wellness Sports Sanitizer Spray Full Throttle and Cornells Wellness Instant Hand Sanitizer Spray, until 8 August 2021 (‘the action of 11 March 2021’). On 15 March 2021, the UK competent authority adopted a similar decision, permitting the making available on the market and use in Northern Ireland of the hand disinfection product Leucillin Family Sanitiser, until 2 August 2021 (‘the action of 15 March 2021’). The UK competent authority informed the Commission and the competent authorities of the Member States of the action of 11 March 2021 and the action of 15 March 2021 and the justification for them, in accordance with Article 55(1), second subparagraph, of that Regulation.












(2)


According to the information provided by the competent authority, the action of 11 March 2021 and the action of 15 March 2021 were necessary in order to protect public health. On 11 March 2020, the World Health Organization (WHO) declared that the outbreak of the coronavirus disease (COVID-19) could be characterised as a pandemic. The Government of the United Kingdom declared the risk to the United Kingdom as ‘high’ and, on 23 March 2020, restrictive measures came into effect. The use of alcohol-based hand disinfectants is recommended by the WHO as a preventive measure against the spread of COVID-19, as an alternative to washing hands with soap and water.












(3)


Cornells Wellness Instant Hand Sanitizer Gel, Cornells Wellness Sports Sanitizer Spray Power Up, Cornells Wellness Sports Sanitizer Spray Full Throttle and Cornells Wellness Instant Hand Sanitizer Spray contain propan-2-ol as an active substance. Leucillin Family Sanitiser contains active chlorine released from sodium hypochlorite as an active substance. Both propan-2-ol and active chlorine released from sodium hypochlorite are approved for use in biocidal products of product-type 1 (human hygiene) as defined in Annex V to Regulation (EU) No 528/2012.












(4)


Since the outbreak of COVID-19, hand disinfectants have been in extremely high demand in the United Kingdom, which has led to unprecedented supply shortages of such products. Prior to the action of 11 March 2021 and the action of 15 March 2021, there were very few hand disinfectants authorised in the United Kingdom in accordance with Regulation (EU) No 528/2012. COVID-19 represents a serious threat to public health in the United Kingdom and additional hand disinfectants are crucial in preventing its spread.












(5)


On 2 August 2021, the Commission received a reasoned request from the UK competent authority to extend the action of 15 March 2021 in the United Kingdom in respect of Northern Ireland, in accordance with Article 55(1), third subparagraph, of Regulation (EU) No 528/2012. On 4 August 2021, the Commission received a similar reasoned request from the competent authority concerning the extension of the action of 11 March 2021. The reasoned requests were made on the basis of concerns that public health might be endangered by COVID-19 beyond the expiry dates of the temporary permits and taking into account that allowing additional hand disinfectants on the market is crucial in order to contain the danger posed by COVID-19.












(6)


According to the UK competent authority, the demand on hand sanitiser supply chains remains high, therefore an extension of the action in the United Kingdom in respect of Northern Ireland is needed.












(7)


Companies that received derogations for hand disinfectants in accordance with Article 55(1), first subparagraph, of Regulation (EU) No 528/2012 after the WHO declaration on the pandemic have been encouraged to seek regular product authorisation as soon as possible. However, no new applications for regular product authorisation have been received by the UK competent authority to date.












(8)


As COVID-19 continues to pose a danger to public health and such danger cannot be adequately contained in the United Kingdom in respect of Northern Ireland in the absence of additional hand disinfectants being allowed on the market, it is appropriate to allow the UK competent authority to extend the two actions in the United Kingdom in respect of Northern Ireland.












(9)


Considering that the actions expired on 2 August 2021 and on 8 August 2021, respectively, this Decision should have retroactive effect.












(10)


The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Biocidal Products,





HAS ADOPTED THIS DECISION:



Article 1
The Health and Safety Executive of the United Kingdom, acting on behalf of the Health and Safety Executive for Northern Ireland, may extend until 10 February 2023 in the United Kingdom in respect of Northern Ireland the action to permit the making available on the market and use of the biocidal products Cornells Wellness Instant Hand Sanitizer Gel, Cornells Wellness Sports Sanitizer Spray Power Up, Cornells Wellness Sports Sanitizer Spray Full Throttle and Cornells Wellness Instant Hand Sanitizer Spray.


Article 2
The Health and Safety Executive of the United Kingdom, acting on behalf of the Health and Safety Executive for Northern Ireland, may extend until 4 February 2023 the action to permit the making available on the market and use of the biocidal product Leucillin Family Sanitiser, in the United Kingdom in respect of Northern Ireland.


Article 3
This Decision is addressed to the Health and Safety Executive of the United Kingdom, acting on behalf of the Health and Safety Executive for Northern Ireland.
Article 1 shall apply from 9 August 2021.
Article 2 shall apply from 3 August 2021.




Done at Brussels, 6 December 2021.


For the Commission

Stella KYRIAKIDES
            

Member of the Commission






(1)  
            OJ L 167, 27.6.2012, p. 1.