Disinfectant Authorisation in the UK

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‘Many disinfectants can currently be sold in the UK without prior authorisation’

This post looks at the regulatory framework for disinfectant authorisation in the UK.

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Why is authorisation of biocides so complicated?

Chemical regulation cartoon

Coronavirus has caused a sharp rise in interest in disinfectant products, ie products that kill micro-organisms and viruses. Disinfectants are a type of biocidal product, along with insecticides, wood preservatives and other product types (PTs). Disinfectants comprise one or more active substances usually combined with other ingredients to give the biocidal product.

The regulatory framework for biocidal products is complicated because two systems are running in parallel. Firstly, a European system, the Biocidal Products Regulations, which covers 23 PTs. This Regulation is comprehensive in scope, but is only partially implemented in the UK owing to a review of the safety of active substances. Secondly, there is UK-specific regulations that apply (see later).

UK BPR and product types (PTs)

Disinfectants are regulated in the UK under the EU Biocidal Products Regulations (BPR) [1]. This legislation is being brought into effect over several years, while biocide active substances are evaluated for safety and efficacy in specific PTs by the EU authorities.

The BPR covers a variety of disinfectants under the following PTs:

  • PT1: Human hygiene for disinfecting the skin or scalp.
  • PT2: General disinfectants and algaecides outside the scope of other product types, eg used for the disinfection of surfaces, swimming pools, air conditioning systems, or incorporated in textiles, tissues, or masks, to produce articles with disinfecting properties.
  • PT3: Veterinary hygiene, ie antimicrobial products used on animals or to disinfect surfaces for housing or transporting animals.
  • PT4: Food and feed area disinfectants used on of equipment and surfaces associated with food or drinking water for humans and animals, or used in food-contact materials.
  • PT5: Used for the disinfection of drinking water for both humans and animals.

Whether a UK supplier requires an authorisation of their disinfectant under the BPR depends on decisions in the EU review programme about the active substances/PT combination (see table below).

EU review programme for active substances

Most active substances for disinfectants have been marketed in products for years. These ‘existing’ active substances (ie on the market on 14 May 2000), are being reviewed for use in their PTs (details are given in the Review Programme Regulation [2]). The programme has been underway for many years, and is set to finish in 2024.

If you are a supplier wishing to market a disinfectant in the UK, then you need to know where the active substance/PT combination is in the review programme. This can be found on the ECHA website.

Here are the possible active-substance statuses, and the consequential authorisation requirements under the BPR:

Table

Active substance status in the review programConsequences for UK product authorisation
1All the active substances in the product are approved in the correct PTThe disinfectant requires UK BPR product authorisation before it can be supplied. Details of the product authorisation process can be found on the HSE website.
2One or more active substances in the product are still being evaluated in the correct PTThe disinfectant can be supplied in the UK without needing BPR product authorisation (until the final active substance is approved in the correct PT). However, you must source the active substance from an approved supplier, and comply with classification and labelling requirements. National authorisation schemes may apply (see below).
3One or more of the active substances in the product has been withdrawn or rejected from the review programmeThe disinfectant cannot be supplied in the UK.

Other UK biocidal product authorisation schemes

In addition to the BPR [1], there are older, UK-specific regulations for biocidal products as follows:

  • The UK-specific Control of Pesticides Regulations (COPR) [3], regulates several biocidal product types, but fewer than the BPR, and specifically excludes disinfectant products from its scope.
  • Animal disinfectants should be approved under a scheme run by the UK Department for Environment, Food & Rural Affairs (DEFRA) [4].
  • The Drinking Water Inspectorate authorise drinking water disinfectants [5].

In the first scenario in the table, where the active substance/PT combination has been approved at EU level, the supplier must apply for authorisation under the BPR to continue marketing it. During this authorisation process, the product can continue to be marketed in the UK, under national rules, up to three years after the date of the approval of the active ingredient.

In the second scenario, where the active substance is still under review, national provision for authorisation apply. Therefore, only in the specific cases of animal and water drinking water disinfection is UK authorisation required, and many disinfectants can currently be sold in the UK without prior authorisation.

Finally, in the third scenario, where the active ingredient/PT combination has been withdrawn or rejected from the review programme, then the disinfectant cannot be marketed in the UK.

Emergency provisions for hand sanitisers

Since the coronavirus outbreak, the UK Health and Safety Executive have taken emergency measures to allow suppliers to market some hand-sanitizing products without the usual requirement for authorisation [6].

Many hand sanitising products contain ethanol (alcohol) as an active substance. Ethanol is still in the review programme for PT1 (ie scenario 2 in the table). Therefore, alcohol-based hand sanitisers can be marketed in the UK without authorisation, as it is not yet subject to authorisation under the BPR, and such products are outside the scope of UK-specific biocide regulations. The ethanol should be sourced from an approved supplier. Such suppliers can be found on the ECHA website.

The situation is more complicated for products containing the active substance isopropanol (CAS 67-63-0). This substance has been reviewed at EU level for PT1 (human hygiene), and had an approval date starting 1 July 2016. This should require the product to be authorised under the BPR before marketing can begin in the UK, see scenario 1 in the above table.

But during the current emergency, hand sanitisers containing isopropanol can be marketed in the UK provided the supplier:

  • Uses a specific formulation, as published by the World Health Organisation [7].
  • Obtains confirmation from the HSE that it is OK to supply the sanitizer (through an Article 55 exemption)
  • Ideally, sources the active substance from an approved supplier (BPR Article 95), although the HSE have stated they might be flexible on this requirement [6].

The situation is similar for products using propan-1-ol (CAS 71-23-8), which was approved for PT1 in May 2019. However, no WHO formulation is available for these products, so the HSE Article 55 exemption requires more information for the the Article 55 exemption.

References

[1] Regulation (EU) No. 528/2012 Concerning the Making Available on the Market and Use of Biocidal Products (as amended). [back]

[2] Commission Delegated Regulation (EU) No 1062/2014 on the Work Programme for the Systematic Examination of All Existing Active Substances Contained in Biocidal Products Referred to in Regulation (EU) No 528/2012. [back]

[3] The Control of Pesticides (Amendment) Regulations; Statutory Instrument 1997 No. 188; 30th January 1997. [back]

[4] The Diseases of Animals (Approved Disinfectants) (England) Order, 2007. [back]

[5] The Water Supply Regulations 2010 (S.I. 2010/991). [back]

[6] https://www.hse.gov.uk/news/hand-sanitiser-manufacture-supply-coronavirus.htm. [back]

[7] https://www.who.int/gpsc/5may/Guide_to_Local_Production.pdf. [back]

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