The Ministry of Ecological and Inclusive Transition publishes an FAQ on hydroalcoholic products

This detailed FAQ complements our previous one item which gave you all the information to bring hydroalcoholic gels and solutions into compliance during the current health crisis.

Coronavirus COVID-19: Hydro-alcoholic gels and solutions

1. What types of products (TP) do hydro-alcoholic gels and solutions fall under the Biocides Regulation and how can they be placed on the market under normal circumstances?

2. What is it allowed to manufacture and market during the crisis?

3. Who is authorized to manufacture and market hydro-alcoholic gels and solutions during the crisis, under an exceptional regime?

4. Labelling, safety data sheets (SDS), product and composition declarations: what obligations remain applicable to products manufactured under the derogatory regime?

5. Under what conditions can a company or legal person that does not fall into any of the categories of establishments provided for in the amended decree of 13 March 2020 initiate the production of small quantities of hydro-alcoholic products, while remaining under the derogatory regime?

6. Under what conditions can a company place on the market TP1 disinfectant products that are not part of the compositions authorized by the amended derogating decree of 13 March 2020?

7. Is the importation of hydro-alcoholic gels and solutions allowed during the crisis?

8. What obligations apply to companies subject to the ICPE regime that temporarily manufacture hydro-alcoholic gels and solutions or temporarily increase their production capacity?

9. Who should information about hydro-alcoholic gels and solutions or the raw materials used in their manufacture in the event of a shortage?

10. Hydro-alcoholic gels and solutions benefit from a favorable regime to fight against the shortage, what about other disinfectants?

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1. What types of products (TP) do hydro-alcoholic gels and solutions fall under the Biocides Regulation and how can they be placed on the market under normal circumstances?

Hydro-alcoholic gels and solutions are biocidal products (type of product TP1 - human hygiene) whose marketing and use (in particular exclusively within a company) are regulated by European Regulation (EU) No. 528/2012.

Except for the derogation detailed below, in order to be placed on the French market, these products must:

• or have a marketing authorization (MA) issued by ANSES (if all the active substances contained in the product have been approved at European level for the TP concerned);
• or have been declared at the national level pending the approval of the active substances contained in the product and the obtaining of marketing authorization (so-called transitional period).

The list of active substances and their status for each TP (approved/under evaluation/refused) is available on the ECHA website (note in particular that isopropanol is approved in TP1 and ethanol is being evaluated for approval in TP1 and ethanol is being evaluated for approval in TP1) Over here.

2. What is it allowed to manufacture and market during the crisis?

The decree of 6 March 2020 and the decree of 13 March 2020 with their amending orders authorize the making available on the market and the use of certain hydro-alcoholic products (solutions and gels) falling under the biocidal product type 1 (disinfectants for human hygiene). The amended decree of 13 March specifies in its annexes the compositions of the biocidal products (hydro-alcoholic solutions) concerned, of which there are 4 (as of 20 April 2020 but the derogation decree may still be amended).

The decree of 13 March also regulates the industrial origin of these products, which in order to be placed on the market and used must have been manufactured by certain companies, without prejudice to the regulations also applicable in terms of taxation, worker protection, and ICPE supervision. This manufacturing must therefore take place in France, except for manufacturing establishments abroad that placed disinfectants on the French market and declared disinfectants before 13 March 2020 (see question 7).

Consolidated version of the decree of 13 March 2020 Over here.

For companies that marketed hydro-alcoholic gels and solutions before the COVID-19 crisis, the conditions remain unchanged: they can continue to market their gels and solutions according to their usual composition. They also benefit from certain temporary facilities in the same way as manufacturers of derogating products, in particular as regards suppliers of active substances.

Businesses can also start placing products on the market under the normal regime, without benefiting from the derogation.

Special case of pharmacies

The Ministry of Solidarity and Health gave the competence to dispensary pharmacies and pharmacies for indoor use to manufacture certain hydro-alcoholic products by its decree of 6 March 2020, repealed and replaced by the decree of 23 March 2020 prescribing the measures for the organization and functioning of the health system necessary to deal with the Covid-19 epidemic as part of the state of health emergency. This derogation, provided for by the Public Health Code, concerns two formulations of hydro-alcoholic products listed in the annex to this decree.

The Ministry of Ecological and Inclusive Transition has regulated the marketing of these products manufactured by pharmacies under the biocides regulation by the decree of 6 March 2020.

The pharmacist exemption is currently valid until May 31, 2020. It is more restrictive, in its scope, than the regulations on biocides described before this box for productions by manufacturers.

Order of 23 March 2020 prescribing the measures for the organization and functioning of the health system necessary to deal with the Covid-19 epidemic as part of the state of health emergency

Order of 6 March authorizing, by derogation, the making available on the market and the temporary use of certain hydro-alcoholic products used as disinfectant biocides for human hygiene

3. Who is authorized to manufacture and market hydro-alcoholic gels and solutions during the crisis, under an exceptional regime?

To date, it is authorized to market hydro-alcoholic gels and solutions according to the derogatory system, i.e. the formulas specified in the decree of 23 March 2020 for pharmacies, and in the decree of 13 March 2020 amended for other establishments:

• dispensary pharmacies and pharmacies for domestic use (see box in question 2 for the restriction of formulations that can be placed on the market),
• establishments manufacturing cosmetic products provided for in Article L. 5131-2 of the Public Health Code,
• pharmaceutical establishments for the manufacture of medicinal products for human use defined in 1° of article R. 5124-2 of the Public Health Code,
• establishments manufacturing biocidal products that declared before 13 March 2020 a product belonging to one of product types 1, 2 3, 4 or 5 under Article L. 522-2-I of the Environmental Code, which may be foreign establishments,
• installations classified for the protection of the environment.

Order of 13 March 2020 amended

These companies must comply with the regulations in force concerning taxation, the protection of workers, the ICPE regulations (see question 5), or the exemption from the public health code for production by pharmacies.

The placing on the market and use of these products is authorized until September 1, 2020.

4. Labelling, safety data sheets (SDS), product and composition declarations: what obligations remain applicable to products manufactured under the derogatory regime?

Labelling

Due to the urgency associated with the crisis, tolerance was granted for the first batches, in particular with regard to the labelling of the active substance concentration. In order to provide better readability, an evolution of labelling with the addition of the active substance concentration (in V/V) will gradually take place. In order to allow producers to sell labels that have already been issued, this new obligation will come into force at the latest for batches manufactured as of May 31, 2020.

Safety Data Sheets (SDS)

SDS are the communication tool on the dangers and risks of chemical products: the information they mention makes it possible to ensure the proper management and handling of products. The manufacture of a mixture, as is the case for hydro-alcoholic gels and solutions, results in the development of an SDS which thus mentions information on the manufacturer, the composition of the mixture, the hazard properties of this mixture, its physical and chemical characteristics, as well as its physical and chemical characteristics, as well as first aid actions and risk management measures in the event of an accidental spill or fire.

The provision of SDS continues to be required as soon as the products are delivered to professionals (healthcare personnel, companies that provide hydro-alcoholic products for their employees, police officers, policemen, paramedics, pharmacists,...), i.e. the vast majority of cases (retailers are professionals and must therefore also have SDS). This provision must be made free of charge at the time of sale.

To facilitate the implementation of this regulatory provision, FDS-models were produced by INERIS based on the compositions of the 4 derogatory formulations of the amended decree of 13 March 2020. Each company therefore has the possibility of taking on its own the model corresponding to its production by adapting it to its case, on the one hand by providing the missing information, and on the other hand by modifying the information mentioned if necessary, in particular if the composition differs.

Each company is responsible for the information that is provided in the SDS that it produces and makes available to its customers or employees.

The SDS models are available on the website of the Ministry of Ecological and Solidarity Transition at This address.

SIMMBAD and SYNAPSE declarations

Because of the emergency linked to the crisis, and only for companies that place a product on the market under the derogatory regime of the orders of 6 and 13 March, they benefit from tolerance with regard to the SIMMBAD declaration and the SYNAPSE declaration. These provisions are no longer required for TP1 products complying with the compositions indicated in the annex to the amended decree of 13 March 2020. These tolerances only apply under this derogatory regime and therefore only until 1 September (except in the event of an extension of the application of ministerial orders). Companies that wish to continue the production of gels and hydro-alcoholic solutions beyond this period will have to comply with the reporting obligations.

Products placed on the market without derogations must meet all obligations (labelling, SDS, declarations).

5. Under what conditions can a company or legal person that does not fall into any of the categories of establishments provided for in the amended decree of 13 March 2020 initiate the production of small quantities of hydro-alcoholic products, while remaining under the derogatory regime?

Any company whose current activities do not allow it to benefit from the derogatory conditions established by the ministerial orders issued during the crisis, which wishes to launch the manufacture of hydro-alcoholic products must first produce an ICPE declaration on the site service-public.fr: Over here.

She can contact the DREAL in her region for support.

This declaration makes it possible to acquire the status of a classified installation for the protection of the environment (ICPE) by making yourself known to the administration, which opens the rights provided for by the ministerial orders taken during the crisis.

Items to be declared online on the service-public.fr site

The declaration must include the minimum elements expected in the context of such a declaration: these elements are specified in the online declaration form. With regard to the nature and volume of activities to be declared, the activity under heading No. 2630 should be declared as follows:

• Item number: indicate “2630" (Manufacture of or based on detergents and soaps)
• Regime: select “Declaration”
• Quantity: indicate the maximum daily tonnage projected by your site (Attention: the minimum to be declared is 1 ton/day to be able to benefit from the declaration)

The quantity actually produced may be less than the declared quantity, and even below the threshold of 1 tonne/day.

The company must then comply with the safety regulations issued by the ministerial decree of general requirements of 5 December 2016 associated with section No. 2630 (which in particular protects it from the risk of fire). If she has difficulty applying these rules, she can contact the DREAL in her region to study how to adapt to these rules.

Link to the ministerial decree setting out general requirements applicable to declarable sites under heading No. 2630: hither

NOTE: And for production in larger volumes?

For businesses that intend to manufacture large quantities of hydro-alcoholic products, namely:

• requiring the storage of 50 tons or more of flammable liquids category 2 (accumulation of quantities on site of ethanol, propan-1-ol, propan-2-ol, finished hydro-alcoholic products in particular),
• and/or requiring the storage of 2 tons or more of oxidizing liquids of categories 1, 2 or 3 (accumulation of all the oxidizing liquids stored on site, in particular hydrogen peroxide when stored in a form whose concentration exceeds 50%),

respectively and as the case may be, statements* under the following headings:

• No. 4331 “Flammable liquids of category 2 or category 3 excluding heading No. 4330",
• No. 4441 “Oxidizing liquids category 1, 2 or 3”

are to be produced on the service-public.fr site.

In all cases, these declarations allow the activity to be started immediately as for the declaration in section No. 2630.

*Attention, for an immediate start of the activity, the quantities stored and produced must not exceed the upper threshold of the declaration regime

6. Under what conditions can a company place on the market TP1 disinfectant products that are not part of the compositions authorized by the amended derogating decree of 13 March 2020?

Companies may wish to market a TP1 disinfectant product with compositions different from those indicated in the annex to the amended decree of 13 March 2020. This product may be based on alcohol (ethanol, isopropanol...) or based on other active substances included in the review program of the biocidal regulation for TP1 (sodium hypochlorite, peracetic acid, hydrogen peroxide, etc.). As it stands, this product cannot benefit from all the derogations allowed by this decree and the conventional obligations therefore apply.

• Case of a biocidal product containing at least one active substance in the process of being approved at Community level (example: ethanol).

In this case, the product is in a transitional period and only national provisions apply.

The obligations associated with this period are as follows:

• the initial marketing must be declared in SIMMBAD, as well as the annual quantities placed on the market (Over there);
• the composition must be declared on SYNAPSE (Over here);
• labelling must comply with the provisions of article 10 of the decree of 19 May 2004 ().

In normal times, the supplier of the active substance must comply with the obligations of article 95 of the BPR, and therefore be in the list made available by ECHA on its website.

In order to facilitate the supply of active substances, the amended decree of 13 March 2020 allows marketers of TP1 biocidal products (including those that do not comply with the compositions in the annex to the decree), TP2 and TP4 to use the references cited in the annex to the amended decree of 13 March 2020, with regard to possible sources of ethanol and isopropanol.

• Case of a biocidal product containing one or more active substance (s), all already approved at Community level (example: propan-1-ol, isopropanol, hydrogen peroxide).

In this case, the person placing on the market must necessarily comply with the provisions of the Regulation on biocidal products concerning the placing on the market of products under a permanent regime, namely:

• Have submitted an application for marketing authorization before the date of approval of the last active substance approved in the product (this precedence authorizes him to leave his product on the market);
• Or have a marketing authorization issued by ANSES.

7. Is the importation of hydro-alcoholic gels and solutions allowed during the crisis?

Exemptions for production and marketing mainly relate to products manufactured in France only, with the exception of manufacturers of biocidal products located abroad who declared disinfectant products (TP1 to 5) in SIMMBAD before 13 March 2020. The latter are the only foreign producers who can benefit from the derogatory conditions, in accordance with article 2 of the decree of 13 March 2020.

For other imported products, conventional biocides regulations apply.

• If the product is based on ethanol or another active substance on the Biocides Regulation Review Programme (BPR) and not yet approved, the product is in a transitional period and national provisions apply. The product can be placed on the French market via a declaration on SIMMBAD, a declaration of the composition on SYNAPSE, and compliance with the labelling rules of article 10 of the decree of May 19, 2004.
• If the product is based on isopropanol (propan-2-ol) or another active substance approved under the BPR, the product is no longer in a transitional period and must comply with the provisions relating to applications for marketing authorizations (marketing authorizations). In particular, if the product has an MA in another EU country, an application for sequential mutual recognition must be submitted to France, and it is only after the evaluation carried out by ANSES that the product can be placed on the French market.

8. What obligations apply to companies subject to the ICPE regime that temporarily manufacture hydro-alcoholic gels and solutions or temporarily increase their production capacity?

In general, since the projected volume of activity does not fall under the registration regime or the authorization regime but only under the declaration regime, companies can start their activity as soon as they have filed their declaration on the service-public.fr site.

For sites that did not have activities involving the handling or storage of flammable liquids, the applicable obligations are as follows:

• Compliance with the ministerial decree of general requirements of 5 December 2016 associated with section No. 2630. This ensures fire risk management.
• In the event that the operators of these sites cannot comply with all the obligations arising from the decree of 5 December 2016, in particular with regard to the fire behavior of buildings (paragraph 2.4 of Annex I of the decree), they should report themselves to the DREAL by requesting the adjustment of the requirements by additional prefectural decree (the development, if the safety conditions seem serious, will be taken in application of articles L.512-10). and R.512-52 of the Environmental Code).

For sites that already carried out ICPE activities involving the handling or storage of such substances and were duly classified for these activities, the contact of manufacturers within DREAL may consider that no change is needed, or that it is appropriate, by complementary prefectural decree, to specify the main requirements for controlling the dangers and disadvantages associated with increases in capacity and/or the implementation of this new activity.

Thus, in general, except of course if a Seveso threshold for the storage of dangerous products is crossed (in particular under headings No. 4331 and No. 4441), the changes will not be considered substantial, as they are expressly activities. temporary and specified as such by the operator who will have reported himself in advance to DREAL.

9. Who should information about hydro-alcoholic gels and solutions or the raw materials used in their manufacture in the event of a shortage?

The Direction Générale des Entreprises (DGE) supported the establishment of a platform that centralizes information relating to the supply and demand of hydro-alcoholic gels and solutions: https://stopcovid19.fr/

It is important that companies report themselves on this platform in order to be put in touch with suppliers and customers and so that the State can monitor supply and demand as much as possible.

A generic email address allows you to contact the DGE: gelcoronavirus.dge@finances.gouv.fr

The DGE will send a list of raw material suppliers to companies that are having difficulties in obtaining supplies, all reported cases having been resolved in the last ten days or so.

10. Hydro-alcoholic gels and solutions benefit from a favorable regime to fight against the shortage, what about other disinfectants?

In particular biocidal products used in TP2 (disinfectants and algicide products not intended for direct application to humans or animals) and used in TP4 (surfaces in contact with foodstuffs and animal feeds). Can manufacturers wishing to manufacture biocidal products of type 2 or 4 benefit from the derogating provisions of the amended decree of 13 March 2020?

As things stand at present, there are no plans to extend to type 2 (surface disinfection not in contact with foodstuffs) or type 4 (surface disinfection in contact with foodstuffs) disinfectant products the provisions made for hydro-alcoholic solutions in the amended decree of 13 March, with the exception of temporary relaxations on sources of raw materials.

Following the decree amending the decree of 13 March 2020 dated 3 April 2020, producers of disinfectant products TP2 and TP4 (surface disinfection not in contact with foodstuffs) based on ethanol or isopropanol based on ethanol or isopropanol can now benefit from the derogation from article 95 of the biocides regulation granted to producers of TP1 disinfectant products.

They can therefore obtain active substances from suppliers not listed by ECHA, within the limits of the other standards mentioned in the annex to the decree of 13 March.

These other possible sources are:

• For isopropanol: EU pharmacopoeia, ethyl alcohol of agricultural origin within the meaning of Annex 1 of Regulation (EC) No. 110/2008 and natural ethanol in accordance with standard EN 15376:2014 (including bioethanol);
• For isopropanol: EU pharmacopoeia

On the other hand, they do not benefit from the rest of the derogating provisions of the amended decree of 13 March and must comply with the other marketing conditions of the transitional regime (for ethanol-based products) and conventional (for isopropanol-based products).

In fact, the Ministry of Solidarity and Health does not identify a shortage for these products (in particular because of a greater number of usable active substances, namely a hundred, and several thousand products on the French market).

It is essential to ensure the correct supply of TP2 and TP4 biocidal products. The Ministry of Ecological and Inclusive Transition and the Ministry of Economy and Finance are working on the subject, in order to precisely identify producers and to guide actors in need of disinfectants. In addition, work is under way with ANSES, other ministries and representatives of manufacturers to identify criteria to ensure their effectiveness on the SARS-CoV-2 virus.

See also: Site of Ministry of Ecological and Inclusive Transition

Do you want to know more about the marketing of hydroalcoholic gels and solutions?

For more information, do not hesitate to contact our experts.