Alcohol-Based Hand Sanitisers – A Short Introduction to Biocides Regulation

In response to the Covid-19 pandemic, a number of distilleries and beverage firms in Ireland have reconfigured their operations in order to produce hand sanitiser gel products. Although this practice is to be commended, there are regulatory requirements to be aware of. The following is intended as a brief introduction to this area, which may be of value to organisations seeking to produce these types of products.
 

“Biocides”

Biocidal products (or biocides) are pesticides or any antimicrobial agent used to prevent, destroy or control harmful or unwanted organisms.  Accordingly, hand sanitisers that make general claims in relation to an antibacterial action or killing of germs (such as alcohol-based hand sanitiser gels) are classified as biocides.

In Ireland, these biocides are regulated by Regulation (EU) No. 528/2012, commonly known as the Biocidal Products Regulation (“BPR”), and by the European Union (Biocidal Products) Regulations 2013 (S.I. 427/2013). The competent authority for biocidal products in Ireland is the Department of Agriculture, Food & the Marine (“DAFM”). At European level, the relevant authority is the European Chemicals Agency (“ECHA”).

If a product mixture has a biocidal function - i.e. it is placed on the market with a purpose of protecting humans against harmful organisms through the action of the active substance it contains - an authorisation must be obtained. One of the requirements for the granting of such an authorisation is that the active substance (“AS”) in the product has been approved for use in that product-type (“PT”). For example, if supplying an anti-microbial hand sanitizer gel, the active substance contained in the product must be approved for the designated product-type 1 (PT-1: human hygiene biocidal products.

It should also be noted that an active substance that remains under evaluation as part of the Review Programme provided for in Article 89 of the BPR (in respect of examination of existing active substances of biocidal products already on the market on 14 May 2000), is subject to transitional provisions laid down in Article 89 allowing biocidal products such an active substance (for a given product-type) to be made available on the market and used, subject to national rules, until three years after their approval. Ethanol is a good example of such a substance benefiting from transitional rules.

Ordinarily, a biocidal product cannot be made available on the EU market unless it has satisfied the pre-market authorisation requirements provided for in Articles 17 and 19 of the BPR and/or the AS/PT combination is from a supplier on the ECHA-maintained Article 95 list (those suppliers accepted by ECHA as having a complete AS/PT combination dossier). However, the BPR also provides a fast-track process for use in exceptional circumstances.

At the national level, an application for product notification must be submitted to DAFM and the product listed on DAFM’s biocidal product register before the product can be made available on the Irish market. Only notified and authorised products listed on the registers maintained by DAFM are permitted to be offered for sale and used in Ireland.

 

Derogations

Action can be taken at the EU or Irish level, depending upon the content of the product.

EU Level

The Pesticides Control Division of DAFM has issued further guidance clarifying that if a product contains an approved active substance, an Article 55 derogation to the authorisation is required. This information can also be submitted using the notification application form.

At the EU level, Article 55 of the BPR allows member states to bypass the ordinary BPR authorisation requirements in an extraordinary situation such as a public health emergency. The relevant competent authority (DAFM) notifies the derogation they have applied in their territory to the European Commission and competent authorities in other Member States. These national derogations cannot exceed 180 days but may be extended by the Commission for an additional 550 days, on submission of a reasoned request.

Companies looking to quickly access the market with disinfectants that contain an approved active substance can therefore apply to the Pesticides Registration and Control Division in DAFM, for special permission with reference to Article 55(1) of the Biocidal Products Regulation (BPR). 

Irish Level

The Pesticides Control Division of DAFM has also issued further guidance clarifying that if a product contains an active substance still under review or ‘in progress’ such as ethanol, the product falls under transitional measures and a notification application form must be submitted. This information can also be submitted using the notification application form.

Access to the Irish market for products containing ethanol as an active substance may still be granted subject to national rules therefore, and a recently updated list of approved PT1 health products published by DAFM (available here), identifies a number of distilleries that have secured approval for products containing ethanol as an active substance. 

 

Labelling

DAFM have also confirmed that the product label with the PCS number (application number provided after submission of application) in the specified format is required to complete an application, and the product must not be marketed in Ireland until the Pesticides Control Division receives and approves final draft product labels for each pack size in which the product will be marketed.

The final label must include the following elements:
 

• The CLP (Classification, Labelling and Packaging) classification as prescribed in section 2.2 of the product Safety Data Sheet. This should be included in a separate text box with pictograms, hazard statements and precautionary statements.  CLP information in respect of ethanol is available here.
• The PCS number must be placed in the bottom right hand corner of the CLP information text box.
• The exact same product name from the application form with no deviation.
• The exact name of the active substance(s) as specified in the review programme on ECHA website.
• The exact content of the active substance(s).
• The relevant instructions for use.
• The type of formulation (e.g. AL other liquid to be applied undiluted).
• Name and address of the Notification holder.
• The following statements must also be placed on the label:
  • Use biocides safely and sustainably.
  • It is illegal to use this product for uses or in a manner other than prescribed on this label.
  • Dispose of contents/container in accordance with local regulations.       
  • Poisons Information: For information or to report a poisoning incident contact The National Poisons Information Centre (01 8092166). 

Further Information

Further guidance and information issued by the Pesticides Control Division of DAFM can be found here.

The ECHA have also issued a useful Q&A document aimed at companies seeking to make available on the EU market disinfectants for the purpose of managing the Covid-19 pandemic, available here.

World Health Organisation information in relation to local production of handrub formulations is also available here.

Written by James Gallagher

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