Category Archives: Regulation

EC Guidance on applicable legislation for hand cleaners and hand disinfectants

Guidance on the applicable legislation for leave-on hand cleaners and hand disinfectants (gel, solution, etc.)1

BACKGROUND

Following the spread of the Coronavirus (COVID-19) disease many actions have been carried out in EU to prevent and reduce the transmission of the virus. This includes enhanced hygiene practices. As preventive measure against the spread of Coronavirus (COVID-19) disease, the European Centre for Disease Prevention and Control recommends “Washing of hands with soap and water for at least 20 seconds, or cleaning hands with alcohol-based solutions, gels or tissues is recommended in all settings”.

The use of hand cleaners and hand disinfectants in forms of gels, hand wipes or other leave-on products has increased dramatically in the last weeks and this has resulted in general shortages across most EU countries. Several economic operators, mostly SMEs, are investing/considering to shift production chain and increase production of Hand cleaners and Hand disinfectants to respond to the additional needs in the context of the current Coronavirus crisis. In that sense, we have noticed a steep increase in the submission to the Cosmetics Product Notification Portal under the Cosmetics Regulation (Article 13) and related questions on the applicable legislation. In fact, according to several factors (e.g. claims, composition and purpose of use), hand cleaners and hand disinfectants are subject to different legal frameworks: Cosmetic Products Regulation or Biocidal Products Regulation.

Clear guidance for economic operators on the applicable legislation and related requirements is urgently needed. This guidance is based on existing practices and practical examples. In particular, while normally soap is a cosmetic product, other products such as alcohol-based solutions, gels, hand-cleaners, hand-disinfectants, etc. might require further clarification.

Q1: WHICH ARE THE APPLICABLE EU LEGAL FRAMEWORKS IN THE CASE OF ALCOHOL-BASED SOLUTIONS, GELS, HAND-CLEANERS, HAND-DISINFECTANTS?

These products can be subject either to Cosmetic Products Regulation or Biocidal Products Regulation (normally only one legislation should be applicable to a product).

This depends first of all on the presence of an active substance and the main purpose of the product:

Products supplied with a main or exclusive cosmetic purpose (i.e. cleaning or cleansing the skin notably in absence of water rinsing) are covered by the Cosmetics Regulation.

1 N.B. These Guidelines are intended only to facilitate the application of Regulation (EU) 1223/2009 on cosmetics products, and Regulation (EU) 528/2012. However, the Commission accepts no responsibility or liability whatsoever with regard to the information in this document. This information is:
• of a general nature only and is not intended to address the specific circumstances of any particular individual or entity;
• not necessarily comprehensive and complete;
• not professional or legal advice.

Products containing an active substance and supplied with a primary biocidal purpose (i.e. intended to control harmful organisms) are not covered by the cosmetics legislation and therefore fall within the scope of the biocides legislation. Examples include products containing an active substance and making a claim to improve public health through the control of infectious organisms, such as “disinfecting”, “kill viruses”, “kill bacteria”, which would go beyond the general perception of personal hygiene and can include antibacterial hand gels.
Therefore:
• When their main purpose is to cleanse or clean the skin they are probably subject to the Cosmetic Products Regulation.
• If no main purpose is declared and such products contain an active substance and are marketed with any claims of biocidal activity or specific effects of reducing cross- contamination, they would be probably subject to the Biocidal Products Regulation.

Q2: WHAT KIND OF CLAIMS WOULD SUPPORT A COSMETIC PURPOSE AND CLASSIFICATION FOR HAND CLEANERS?

Although the claims themselves are not the only decisive factor whether the product should be considered as covered by the Cosmetics Regulation or the Biocidal Products Regulation, they are a relevant indication of the purpose of the product. “Physically clean / visually clean” and “Hand cleaner” are typical claims where the function is in line with the definition of a cosmetic product with respect to cleaning and improving the appearance of the hands or body. The product will have to comply with the Cosmetic Products Regulation.

However, if the product is presented with a claim stating “Hygienically clean” (or similar wording), the function ‘hygiene’ might indicate in this context that it could be considered as biocidal. The term hygiene has a broad spectrum of meaning which range from simple cleanliness to disinfection, depending on the context in which it is used. While in the context of cosmetics, the term normally refers to ‘personal hygiene’, i.e. products for cleaning and keeping in good condition the skin, in a context of biocidal products, the term ‘hygiene’ is associated with ‘disinfection’.

It is therefore important to look at all the characteristics of the product, and in particular its composition, the purpose and the function of the product. If it is clear that the product is mainly intended to protect public health through biocidal action (e.g. disinfecting, antimicrobial/virus function), which would go beyond the general perception of personal hygiene, and the objective criteria for considering such a product as “biocidal product” are fulfilled, the product cannot be considered as a cosmetic product and will have to comply with the Biocidal Products Regulation.

Q3: WHAT KIND OF CLAIMS WOULD PRELIMINARILY SUPPORT A CLASSIFICATION AS BIOCIDAL PRODUCT CLASSIFICATION FOR HAND-CLEANERS AND HAND-DISINFECTANT?

The following list of examples is established solely on the basis of product claims. Claims may be a strong indication of the intended product purpose and will therefore help in forming a preliminary assumption on a product’s regulatory status. However, it is important to assess all the characteristics of the product, including its composition, the purposes of its use and the mode of action on the harmful organism, on a case by case basis before making a final decision.
The following claims would preliminarily suggest that the product is a biocide covered by the Biocidal Products Regulation:

• “Antibacterial”
• “Unique antibacterial formulation.”
• “Kills bacteria”
• “Kill bacteria/a wide range of germs and words having the same meaning”
• “Antiviral” and words having the same meaning
• “Kills viruses, Virokill” and words having the same meaning
• “Effective against flu virus H1N1”
• “Effective against coronavirus”
In these examples, the product clearly makes a claim of general human hygiene through skin disinfection, and hence a claim to protect public health through biocidal action. In this case, the biocidal function is likely to be considered as the main function to which the cosmetic function has become secondary. In consequence, if the product contains an active substance and has the required function, the product would be excluded from the scope of the Cosmetics Products Regulation, and would need to comply with the Biocidal Products Regulation.

Q4: I AM A COMPANY PRODUCING COSMETICS, AND I WANT TO MANUFACTURE “HAND DISINFECTANTS” TO HELP IN THE CONTEXT OF AN EPIDEMIC. WHAT SHALL I DO TO BE ALLOWED TO SUPPLY SUCH “HAND DISINFECTANTS” (ON THE MARKET TO THE GENERAL PUBLIC, TO PROFESSIONALS, TO MEDICAL CARE FACILITIES ETC.)?

The supply of “hand disinfectants” is subject to rules established under the Biocidal Products Regulation. You are advised to contact first the national competent authorities on biocidal products in the Member States where you intend to make such a supply2. These authorities will be able to guide you on steps to follow, in particular to obtain an authorisation or an emergency permit if considered necessary by the Member States.

In particular:

– if your hand disinfectant would contain active substances still under examination in the “review programme” set out in Regulation (EU) No 1062/2014 (see Annex II), your hand disinfectant would have to be placed on the market in the Member States subject to compliance with the national rules, and possible derogation therefrom.
– If your hand disinfectant would contain active substances which have been assessed and approved under the Biocidal Products Regulation, the Member States would normally need to grant an authorisation in accordance with the Regulation. Member States can also grant you an emergency permit under Article 55(1) if they consider it necessary to allow your product on the market especially in the context of the current Covid-19 crisis.

You can check the situation of active substances on the European Chemicals Agency website: https://echa.europa.eu/fr/information-on-chemicals/biocidal-active-substances

Further useful links :

• Information on the cosmetic legislation : https://ec.europa.eu/growth/sectors/cosmetics_en
• Information on the biocidal products legislation :
 https://ec.europa.eu/health/biocides/overview_en
 https://echa.europa.eu/regulations/biocidal-products-regulation
 https://echa.europa.eu/de/contact/bpr
http://echa.europa.eu/web/guest/support/helpdesks/national- helpdesks/list-of-national-helpdesks

2 The list of Member States competent authorities on biocidal products can be found here : https://echa.europa.eu/fr/contacts-of-the-member-state-competent-authorities ;
and here : https://circabc.europa.eu/w/browse/73cc1500-d360-4f43-98be-863713c4dd8d

Manufacture of Biocidal Hand Sanitiser -DEROGATION (COVID-19)

MANUFACTURE AND SUPPLY OF BIOCIDAL HAND SANITISER PRODUCTS DURING THE OUTBREAK: coronavirus (COVID-19)

Some of the UK’s existing manufacturers of biocidal hand sanitiser products have reported that they are facing significant challenges to their normal supply chains from increasing demand for the raw ingredients needed to meet unprecedented and urgent demand during the Covid-19 outbreak.

In response HSE has taken the following steps.

* DEROGATION FROM PRODUCT AUTHORISATION REQUIREMENTS FOR HAND SANITISERS CONTAINING Propan-2-ol
Article 55 (1) of the Biocidal Products Regulation (BPR) enables HSE, in cases of danger to public health, animal health or the environment which cannot be contained by other means, to provide short term derogations from the requirements for product authorisation.

Biocidal hand sanitiser products containing Propan-2-ol (also known as isopropanol or isopropyl alcohol/IPA), will not be required to obtain a product authorisation if they meet the relevant WHO-specified formulation II (PDF)- Portable Document Format.

Manufacturers wishing to place products that meet the WHO specified formulation onto the UK Market must contact HSE via biocidesenquiries@hse.gov.uk using ‘Propan-2-ol Article 55’ as the subject title of the email. HSE will respond quickly to request details about the products being manufactured and once provided, issue a derogation certificate.

Products should not be placed on the market until HSE has confirmed that the derogation applies to you and issued you with the certificate.

* HAND SANITISERS CONTAINING Propan-1-ol OR Ethanol
WHO does not specify a formulation for hand sanitisers containing propanol-1-ol. Therefore, although Article 55 derogations may be possible for hand sanitisers containing propan-1-ol, these will require more information from applicants to enable HSE to determine their efficacy and the risks associated with their use. Such applications will take longer to process than those for hand sanitisers containing propan-2-ol.

There is a WHO-specified formulation for hand sanitiser containing ethanol(https://www.who.int/gpsc/5may/Guide_to_Local_Production.pdf). Under the transition arrangements in the biocidal product regulations manufacturers do not require product authorisations to place hand sanitiser products containing ethanol on to the UK Market.

* RULES FOR SUPPLYING CHEMICALS FOR USE IN BIOCIDAL PRODUCTS
Article 95 of the BPR aims to create a level playing field across industry by ensuring that all suppliers of biocidal products have paid a share of the cost of supporting the active substance dossier through an evaluation process.

Article 95 requires suppliers of active substances for use in biocidal products to have obtained a letter of access to an active substance dossier, to have submitted their own dossier to the European Chemicals Agency, or to be a participant in the European Commission’s on-going review programme of active substances.

There are currently 44 companies recognised under Article 95 for supplying propan-2-ol as a biocidal active substance, including 4 based in the UK. In addition, there are currently 98 companies recognised under Article 95 for supplying the alcohol ethanol as a biocidal active substance, including 7 based in the UK.

The sources are listed on the European Chemical’s Agency’s (ECHA) searchable database: https://echa.europa.eu/information-on-chemicals/active-substance-suppliers

* NON-ARTICLE 95 SUPPLIER’S CHEMICALS FOR USE IN HAND SANITISER
During this exceptional time of increased demand due to the coronavirus outbreak, it may be necessary for hand sanitiser manufacturers to find alternative suppliers of raw ingredients to supplement those obtained via regular supply chains.

HSE’s primary concern is that safe and effective biocidal hand sanitisers are available in the UK to help protect people during the coronavirus outbreak. HSE will adopt a pragmatic and proportionate approach to regulatory requirements that relate to supply chain obligations during this period. The focus of any HSE activity by inspectors will be to ensure that products on the market are effective in combating the coronavirus and do not pose an unacceptable risk to people or the environment.

HSE would expect product manufacturers to have taken all reasonable steps to source ingredients in such a way that they are compliant with Article 95 obligations.

However, HSE Inspectors will take a sensible and proportionate approach if they come across hand sanitisers that are not strictly in line with normal BPR supply chain requirements under Article 95, recognising the urgent wider need for safe and effective products.

In making commercial decisions, manufacturers need to be mindful of maintaining high levels of safety and efficacy of the products they make available to the public and others.

* ACTIVE SUBSTANCES NOT YET SUBJECT TO AUTHORISATION UNDER THE BIOCIDAL PRODUCTS REGULATIONS
Suppliers of hand disinfectants and sanitisers should bear in mind that where the product is not yet subject to authorisation under the BPR, eg those containing ethanol, any product placed on the market must comply with other relevant legislation on Classification, Labelling and Packaging of substances and Mixtures (CLP) and other general product safety regulations.

Any workplace producing or using or storing ethanol and isopropyl alcohol must also comply with relevant health and safety regulations.

* HAND SANITISERS THAT DON’T CONTAIN ALCOHOL
This guidance relates to alcohol-based hand sanitisers.

Other active substances are available but Public Health England has advised that hand sanitisers should have 60% or higher alcohol content to be effective against the COVID-19 virus.

Further information and advice
* speak to your supplier
* contact biocidesenquiries@hse.gov.uk
* sign up to the biocides e-bulletin: https://www.hse.gov.uk/news/subscribe/index.htm
* visit the HSE Biocides website: https://www.hse.gov.uk/biocides/index.htm

(COVID-19): support package for your workforce

The Chancellor outlined on 20th March an unprecedented package of measures to protect millions of people’s jobs and incomes as part of the national effort in response to the coronavirus pandemic.

A new Coronavirus Job Retention Scheme will be set up to help pay people’s wages. Employers will be able to contact HMRC for a grant to cover most of the wages of their workforce who remain on payroll but are temporarily not working during the coronavirus outbreak. Any employer in the country- small or large, charitable or non-profit will be eligible for the scheme.

Universal Credit and tax credits will also be increased as part of an almost £7 billion welfare boost, as he outlined one of the most generous business and welfare packages by any government so far in response to Covid-19.

To ease cash flow pressures for UK VAT registered businesses, VAT bills from now until the end of June, will be deferred until the end of the tax year.

* UK workers of any employer who is placed on the Coronavirus Job Retention Scheme can keep their job, with the government paying up to 80% of a WORKER’S WAGE, up to a total of £2,500 per worker each month. These will be backdated to 1st March and will be initially open for 3 months, to be extended if necessary.
* VAT payments due between now and the end of June will be DEFERRED. No VAT registered business will have to make a VAT payment normally due with their VAT return to HMRC in that period. INCOME TAX PAYMENTS due in July 2020 under the Self Assessment system will be DEFERRED to January 2021, benefitting up to 5.7m self-employed businesses.
* Additionally, the Coronavirus Business Interruption Loan Scheme, launched at Budget, will now be INTEREST FREE for TWELVE months.
* The standard rate in Universal credit and Tax Credits will be increased by £20 a week for one year from April 6th, meaning claimants will be up to £1040 better off.
* Nearly £1bn of additional support for RENTERS, through increases in the generosity of housing benefit and Universal Credit. From April, Local Housing Allowance rates will pay for at least 30% of market rents in each area.
HMRC are working night and day to get the unprecedented Coronavirus Job Retention Scheme up and running and we expect THE FIRST GRANTS TO BE PAID WITHIN WEEKS.