Products Update: The Regulation of Hand Sanitizers During COVID-19

COVID-19 has left many manufacturers with surplus stock due to either the compulsory closures of businesses or the lack of consumer confidence in the economy. As a result, many are now attempting to reconfigure their lines of production to both remain in business and also assist in the battle against COVID-19. This is essential for both the health crisis and meeting demand for critical products such as hand sanitizer but also to preserve the economy. However, any products that are produced need to fully conform with the relevant regulations. Manufacturers looking to produce hand sanitizer therefore need to be cognisant of these in order for their product to be placed on the Irish market.

Biocides

A biocidal product, or ‘biocide’, is defined as ‘any substance or mixture, in the form in which it is supplied to the user, consisting of, containing or generating one or more active substances, with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism’.

Products that fall within this definition include disinfectants, hand sanitizers, preservatives, insect repellents, etc. One noteworthy point is that hand sanitizers looking to be classified as a biocidal product must only make general claims relating to their antibacterial action or the killing of germs. They must not, however, make any medicinal claims or contain medicinal substances.

Biocides are regulated like other products to protect human health, animals and the environment by way of controlling how they are manufactured, marketed, sold and used. In Ireland, biocides are controlled by the EU’s Biocidal Products Regulation (BPR)^[1]. The competent authority in Ireland for these products is the Department of Agriculture, Food and the Marine (DAFM).

Legal considerations

Regulatory

A biocidal product must be authorised before it can be made available on the market or used within the EU. This takes place by way of two consecutive steps. Firstly, the active substance (AS) is evaluated at a European Union level and provided relevant criteria are fulfilled it is approved for use in a specified product-type (PT). Secondly, authorisation of each biocidal product is assessed at National level.

In order for National authorities to make a suitable assessment of the exposure and risk to human health and the environment, the EU has developed different product types within the category of biocides. Annex V of the BPR classifies biocidal products into 22 specific product types. National authorities are required to assess the active substances contained in the biocide against the specific product type’s intended use. Therefore, products will be approved for some uses but not others, depending on the risks associated with the use of the active substances. For example, if supplying hand sanitizer, the active substances contained in the biocidal product must be approved for the purpose of disinfecting the skin, falling into the relevant product type PT-1: human hygiene.

Additionally, the AS/PT combination can only be supplied from a supplier listed within the European Chemicals Agency (ECHA) register as per Article 95 of the BPR. Further pre-market authorisation requirements are laid down under Articles 17 and 19 of the BPR.

Furthermore, a product label is mandatory and must be accompanied by its authorisation number (PCS number – provided after submission of application) to complete an application to place a biocidal product on the Irish market. The Pesticide Control Division (PCD) are obliged to approve it in its final format for each pack size in which the product will be marketed before it can be placed on the Irish market. Label requirements have been reduced during COVID-19 and the new requirements can be found from the PCD guidance which is available here. 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

• The PCS number which must be placed in the bottom right hand corner of the CLP information text box

• The product name as per the application form with no deviation

• The name of the active substance(s) as specified in the review programme on the ECHA website

• The content of the active substance(s), you cannot round this figure

• The relevant instructions for use

• The type of formulation, e.g. AL other liquid to be applied undiluted, SL, etc.

• 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).

Products may only be marketed in Ireland with the labels as received and accepted by the PCD.

Consumer protection

As well as regulatory considerations, consumer protections must be considered before attempting to produce hand sanitizer during COVID-19. Whilst businesses face unprecedented pressure at present, consumer law regulators have issued guidance to remind businesses that consumer laws continue to apply. The Competition and Consumer Protection Commission (CCPC) is responsible for enforcing competition and consumer protection legislation in Ireland. They are also the designated Market Surveillance Authority in Ireland for PPE products for consumer use. In the current climate, there is a high demand for hygiene products, such as hand sanitizer. As a result, the CCPC are keeping vigilant with regards to the sale of such products in order to protect consumers. Manufacturers are advised to avoid misleading statements, for example, false representations that a product is capable of curing an illness when it cannot or other prohibited health claims. Aggressive commercial practices or pressurised sales tactics such as ‘price gouging’ towards consumers and unfair contract terms such as attempting to limit consumers’ legal rights directly or indirectly are also impermissible.

Marketing claims

Another legal consideration with regard to producing PPE during COVID-19 is that marketing claims must be supported by robust evidence. The Advertising Standards Authority for Ireland (ASAI) has reminded businesses that any claims being made for products referring to COVID-19 should be adequately substantiated. The ASAI have stated that advertisers are required to avoid claims which undermine public health or exploit consumer’s anxieties. Under the ASAI Code, members must adhere to the ASAI’s Code of Standards for Advertising and Marketing Communications in Ireland, which applies to all commercial marketing communications. As stated in this Code, any marketing communications should not mislead, or be likely to mislead, by inaccuracy, ambiguity, exaggeration, omission or otherwise. The advertiser must be in a position to support all claims, expressed or implied that the advert or statement conveys to reasonable customers through vigorous evidence.

COVID-19 exemptions

Article 55 of the BPR permits Member States to set aside the aforementioned regulatory requirements for market authorisation in the interests of public health emergency situations. National competent authorities are required to notify the European Commission and other competent authorities of any derogation that they have applied within their territory. National derogations from the normal authorisation procedure cannot exceed 180 days, but may be extended on submission of a reasoned request, for a further 550 days by the European Commission.

The Pesticide Control Division (PCD) of the Department of Agriculture, Food and the Marine (DAFM) has implemented derogations in light of COVID-19. PT1 applications are now their main priority and pre-market authorisation requirements have been temporarily set aside. Whereby a biocidal product contains an active substance not yet approved and still under review of the ECHA, for example ethanol, manufacturers are permitted to submit a market application to the PCD^[2]. The PCD aim to respond within one working day and provide a decision on foot of any application within 10 days. They have also implemented a fast tracking procedure for market authorisation by way of Article 55(1), whereby manufacturers seeking to use an already approved active substance but which its date of approval has surpassed; manufacturers can deviate from the rules laid down by Articles 17 and 19. This is relevant for active substances such as isopropyl alcohol (propan-1-ol or propan-2-ol).

Additionally, the ECHA are permitting manufacturers who want to use new sources of propan-1-ol or propan-2-ol to submit a request for technical equivalence (TE). Lastly, the ECHA has reduced information requirements and has implemented a modified, temporary procedure to assess these applications.

Conclusion

The response to COVID-19 is a necessarily fast-moving field especially now as we move to lift restrictions. Ordinarily the process for market authorisation of a biocidal product such as hand sanitizer is time consuming. However, Member States have accommodated for the shortage of such necessary products by implementing a number of derogations under the BPR in light of public health emergency situations. Manufacturers may be permitted to use ethanol as an active substance under the Review Programme, labelling requirements have been reduced and a fast track procedure for market authorisation is now available. Additionally, alternative sources for already approved active substances may be permitted by the ECHA. As a result, manufacturers such as distillers can now enter a new line of production.

Despite these temporary market authorisation derogations implemented in light of COVID-19, a large range of legal considerations remain for those seeking to produce PPE such as hand sanitizer. Manufacturers should obtain legal advice whereby they are unsure of the risks involved before attempting to manufacture hand sanitizer.