What measures were taken to facilitate the commercialisation of hand sanitizers during pandemic?
To face the increasing demand in hand sanitizers caused by the Coronavirus Covid-19 pandemic, the French government decided to authorise the commercialisation of hand sanitizers until 31st May 2020 under specific regulatory conditions. To be able to put them on the French market, companies will need to comply with the two decrees published on 13th et 20th March 2020.
After 31st May 2020, hand sanitizers will not be able to benefit from this exemption. They will have to comply with the Biocidal Products Regulation (BPR) EU n�528/2012 to keep being commercialised (see lower).
Careful, however: hand sanitizers are flammable or combustive products. Their manufacture and/or storage can classify your facilities for regulatory purposes (environment protection). Moreover, a company carrying out operations of transport, packing, filling, loading or unloading must appoint a security advisor under the ADR Regulation.
If you are:
- A pharmaceutical establishment manufacturing medicine for humans as defined in Article R. 5124-2 of the French health code;
- A cosmetic products manufacturing establishment;
- An establishment manufacturing biocidal products having already declared a type 1, 2, 3, 4 or 5 product under the French environment code
- A classified facility under the protection of the environment.
You can benefit from an authorisation by way of derogation for the temporary commercialisation and use of some hydroalcoholic products used as disinfectant biocides for human hygiene.
In this case, you can commercialise, in France, one of the 4 following formulas of hand sanitizers following the indicated compositions and with specific labelling elements, without any other regulatory process.
Ethanol formula recommended by the WHO
ComponentQuantityFunctionStandard
Ethanol 96% V/ V
833.3 mL
Substance active
European pharmacopoeia
or suppliers listed on ECHA's website
or ethyl alcohol of agricultural origin under Annex 1 of regulation (CE) n�110/2008
or natural ehtanol produced under the 15376: 2014 standard
OR
Ethanol 95% V/ V
842.1 mL
OR
Ethanol 90% V/ V
888.8 mL
Hydrogen peroxyde, 3% solution
41.7 mL
Spore inactivating agent
European pharmacopoeia or approved suppliers listed on ECHA's website
Glycerol
14.5 mL
Humectant
European pharmacopoeia
or American Pharmacopoeia (or USP)
or Japanese Pharmacopoeia (or JP)
Purified water q. s.
1000.0 mL
Solvent
European pharmacopoeia
Batch release: before the batch can be released, it must be quarantined for 72 hours to allow the destruction of potential spores present in the alcohol.
Isopropanol formula, recommended by the WHO
ComponentQuantityFunctionStandard
Isopropanol 99.8 % V/ V
751.5 mL
Active substance
European pharmacopoeia or approved suppliers listed on ECHA's website
Hydrogen peroxyde, 3% solution
41.7 mL
Spore inactivating agent
European pharmacopoeia or approved suppliers listed on ECHA's website
Glycerol
14.5 mL
Humectant
European pharmacopoeia
or American Pharmacopoeia (or USP)
or Japanese Pharmacopoeia (or JP)
Purified water q. s.
1000.0 mL
Solvent
European pharmacopoeia
Batch release: before the batch can be released, it must be quarantined for 72 hours to allow the destruction of potential spores present in the alcohol.
Formula recommended by the French decree
ComponentQuantityStandard
Absolute ethanol
650 to 750 mL
European pharmacopoeia
or approved suppliers listed on ECHA's website
or ethyl alcohol of agricultural origin under Annex 1 of regulation (CE) n�110/2008
or natural ehtanol produced under the 15376 : 2014 standard
OR
Ethanol 96% V/ V
675 to 777 mL
OR
Ethanol 95% V/ V
681 to 786 mL
OR
Ethanol 90% V/ V
720 to 830 mL
Glycerin
50 mL
European pharmacopoeia
or American Pharmacopoeia (or USP)
or Japanese Pharmacopoeia (or JP)
One thickening polymer to choose between:
1. CARBOMER : 1,5 � 2 ml + AMINOMETHYL PROPANEDIOL : 0.26-0.35 ml
2. ACRYLATES/ C10-30 ALKYL ACRYLATE CROSSPOLYMER : 1,5 � 2 ml + AMINOMETHYL PROPANEDIOL : 0.26-0.35 ml
3. WATER, ACRYLATES COPOLYMER, SODIUM LAURYL SULFATE : 50-60 ml + AMINOMETHYL PROPANEDIOL : 1-2 ml
4. AMMONIUM ACRYLOYLDIMETHYLTAURATE/ VP COPOLYMER : 3,5 � 10 ml
5. HYDROXYETHYL ACRYLATE/ SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, POLYSORBATE 60, SORBITAN ISOSTEARATE, WATER : 10 � 20 ml
6. POLY ACRYLAMIDOMETHYL ACID SULFONIC PROPANE PARTIALLY NEUTRALISED WITH AMMONIA AND HIGHLY CROSSLINKED 7 ml
Compliant with article 19 paragraph 9 Of Regulation (EU) n� 528/2012
MICROBIOLOGICALLY CLEAN DEIONISED WATER Q. S.
1000.0 mL
Batch release: immediate.
Formula recommended by the French decree
ComponentQuantityStandard
Ethanol 96% V/ V
58 % p/ p (corresponding to 65 % volume at 20� C)
European pharmacopoeia
or approved suppliers listed on ECHA's website
or ethyl alcohol of agricultural origin under Annex 1 of regulation (CE) n�110/2008
or natural ehtanol produced under the 15376: 2014 standard
OR
Ethanol 95% V/ V
59,1 % p/ p (corresponding to 65 % volume at 20� C)
OR
Ethanol 90% V/ V
63,7 % p/ p (corresponding to 65 % volume at 20� C)
Glycerin
OR
Propylene glycol
OR
Butylene glycol
OR
Propanediol
OR
Diglycerin
0,5 to 5 % by weight
European pharmacopoeia
or American Pharmacopoeia (or USP)
or Japanese Pharmacopoeia (or JP)
or compliant with article 19 paragraph 9 of Regulation (EU) n� 528/2012
Polyacrylate Crosspolymer-6
0,4 to 0,8 % by weight
Compliant with article 19 paragraph 9 of Regulation (EU) n� 528/2012
OR
Ammonium Acryloyldimethyltaurate/ VP Copolymer *
0,4 to 1 % by weight
OR
Carbomer neutralised with aminomethylpropanol (AMP) or with soda or with triethanolamin
0,2 to 1 % by weight
OR
Neutralised acrylate copolymer
1 to 3 % by weight
OR
Hydroxyethyl Acrylate/ Sodium Acryloyldimethyl Taurate Copolymer)
0,5 to 2 % by weight
OR
Acrylamide/ Sodium Acryloydimethyl Taurate & Isohexadecane & Polysorbate 80)
1 to 4 % by weight
OR
Acrylates/ C10-C30 alkyl acrylate crosspolymer
0,2 to 1 % by weight
MICROBIOLOGICALLY CLEAN DEIONISED WATER Q. S.
100 %
Batch release: immediate.
Other formulas and how to stay compliant after 31st May 2020
If you do not manufacture these formulas and/or do not fall under the type of companies described in the decree, this exemption does not affect you. You need to comply with regulation 528/2012 regarding the commercialisation of biocidal products, in France.
If you want to manufacture a hand sanitizer with ethanol as active substance, you must:
- Check that the ethanol provider is approved for this use.
- Carry out the poison centre notification: Synapse for France or ECHA�s platform starting on 1st January 2021
- Carry out the Simmbad notification for France (ethanol is still being evaluated)
- Have a compliant SDS under REACH and CLP regulations
- Have a compliant labelling under the biocides regulation n�528/2012
- Check the product�s compliance for topical use
In case of control by the authorities, compliant data on the products efficiency and for this use must be provided.
Be careful, if you do not use ethanol but use isopropanol and/or hydrogen peroxide, you must establish an MA (Marketing Authorisation) because these substances have already been approved under the biocidal regulation. Do not hesitate to contact our experts to know more on MA.
Usual rules for commercialising hand sanitizers
As a reminder, a hand sanitizer is a biocidal product destined to human hygiene (PT1) subject to the BPR EU n�528/2012.
As a consequence, the active substance.s (for sanitizers, alcohol) contained in the formula must be approved or under evaluation, but they must also come from an approved supplier. Moreover, the use being cutaneous, the formula must comply with the cosmetics regulation in order to guarantee maximum safety for the consumer when applied.
Depending on the status of the active substances contained in the product, the regulatory process varies, when putting hand sanitizers on the market. For more information on the matter, do not hesitate to take a look at our key concept on the biocidal MA or to contact our experts.
Wish to know more about biocidal products?
For more information, do not hesitate to contact Fang Zhou or one of our experts via our contact form, indicating the purpose of your inquiry.
What measures were taken to facilitate the commercialisation of hand sanitizers during pandemic?
To face the increasing demand in hand sanitizers caused by the Coronavirus Covid-19 pandemic, the French government decided to authorise the commercialisation of hand sanitizers until 31st May 2020 under specific regulatory conditions. To be able to put them on the French market, companies will need to comply with the two decrees published on 13th et 20th March 2020.
After 31st May 2020, hand sanitizers will not be able to benefit from this exemption. They will have to comply with the Biocidal Products Regulation (BPR) EU n�528/2012 to keep being commercialised (see lower).
Careful, however: hand sanitizers are flammable or combustive products. Their manufacture and/or storage can classify your facilities for regulatory purposes (environment protection). Moreover, a company carrying out operations of transport, packing, filling, loading or unloading must appoint a security advisor under the ADR Regulation.
If you are:
- A pharmaceutical establishment manufacturing medicine for humans as defined in Article R. 5124-2 of the French health code;
- A cosmetic products manufacturing establishment;
- An establishment manufacturing biocidal products having already declared a type 1, 2, 3, 4 or 5 product under the French environment code
- A classified facility under the protection of the environment.
You can benefit from an authorisation by way of derogation for the temporary commercialisation and use of some hydroalcoholic products used as disinfectant biocides for human hygiene.
In this case, you can commercialise, in France, one of the 4 following formulas of hand sanitizers following the indicated compositions and with specific labelling elements, without any other regulatory process.
Ethanol formula recommended by the WHO
ComponentQuantityFunctionStandard
Ethanol 96% V/ V
833.3 mL
Substance active
European pharmacopoeia
or suppliers listed on ECHA's website
or ethyl alcohol of agricultural origin under Annex 1 of regulation (CE) n�110/2008
or natural ehtanol produced under the 15376: 2014 standard
OR
Ethanol 95% V/ V
842.1 mL
OR
Ethanol 90% V/ V
888.8 mL
Hydrogen peroxyde, 3% solution
41.7 mL
Spore inactivating agent
European pharmacopoeia or approved suppliers listed on ECHA's website
Glycerol
14.5 mL
Humectant
European pharmacopoeia
or American Pharmacopoeia (or USP)
or Japanese Pharmacopoeia (or JP)
Purified water q. s.
1000.0 mL
Solvent
European pharmacopoeia
Batch release: before the batch can be released, it must be quarantined for 72 hours to allow the destruction of potential spores present in the alcohol.
Isopropanol formula, recommended by the WHO
ComponentQuantityFunctionStandard
Isopropanol 99.8 % V/ V
751.5 mL
Active substance
European pharmacopoeia or approved suppliers listed on ECHA's website
Hydrogen peroxyde, 3% solution
41.7 mL
Spore inactivating agent
European pharmacopoeia or approved suppliers listed on ECHA's website
Glycerol
14.5 mL
Humectant
European pharmacopoeia
or American Pharmacopoeia (or USP)
or Japanese Pharmacopoeia (or JP)
Purified water q. s.
1000.0 mL
Solvent
European pharmacopoeia
Batch release: before the batch can be released, it must be quarantined for 72 hours to allow the destruction of potential spores present in the alcohol.
Formula recommended by the French decree
ComponentQuantityStandard
Absolute ethanol
650 to 750 mL
European pharmacopoeia
or approved suppliers listed on ECHA's website
or ethyl alcohol of agricultural origin under Annex 1 of regulation (CE) n�110/2008
or natural ehtanol produced under the 15376 : 2014 standard
OR
Ethanol 96% V/ V
675 to 777 mL
OR
Ethanol 95% V/ V
681 to 786 mL
OR
Ethanol 90% V/ V
720 to 830 mL
Glycerin
50 mL
European pharmacopoeia
or American Pharmacopoeia (or USP)
or Japanese Pharmacopoeia (or JP)
One thickening polymer to choose between:
1. CARBOMER : 1,5 � 2 ml + AMINOMETHYL PROPANEDIOL : 0.26-0.35 ml
2. ACRYLATES/ C10-30 ALKYL ACRYLATE CROSSPOLYMER : 1,5 � 2 ml + AMINOMETHYL PROPANEDIOL : 0.26-0.35 ml
3. WATER, ACRYLATES COPOLYMER, SODIUM LAURYL SULFATE : 50-60 ml + AMINOMETHYL PROPANEDIOL : 1-2 ml
4. AMMONIUM ACRYLOYLDIMETHYLTAURATE/ VP COPOLYMER : 3,5 � 10 ml
5. HYDROXYETHYL ACRYLATE/ SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, POLYSORBATE 60, SORBITAN ISOSTEARATE, WATER : 10 � 20 ml
6. POLY ACRYLAMIDOMETHYL ACID SULFONIC PROPANE PARTIALLY NEUTRALISED WITH AMMONIA AND HIGHLY CROSSLINKED 7 ml
Compliant with article 19 paragraph 9 Of Regulation (EU) n� 528/2012
MICROBIOLOGICALLY CLEAN DEIONISED WATER Q. S.
1000.0 mL
Batch release: immediate.
Formula recommended by the French decree
ComponentQuantityStandard
Ethanol 96% V/ V
58 % p/ p (corresponding to 65 % volume at 20� C)
European pharmacopoeia
or approved suppliers listed on ECHA's website
or ethyl alcohol of agricultural origin under Annex 1 of regulation (CE) n�110/2008
or natural ehtanol produced under the 15376: 2014 standard
OR
Ethanol 95% V/ V
59,1 % p/ p (corresponding to 65 % volume at 20� C)
OR
Ethanol 90% V/ V
63,7 % p/ p (corresponding to 65 % volume at 20� C)
Glycerin
OR
Propylene glycol
OR
Butylene glycol
OR
Propanediol
OR
Diglycerin
0,5 to 5 % by weight
European pharmacopoeia
or American Pharmacopoeia (or USP)
or Japanese Pharmacopoeia (or JP)
or compliant with article 19 paragraph 9 of Regulation (EU) n� 528/2012
Polyacrylate Crosspolymer-6
0,4 to 0,8 % by weight
Compliant with article 19 paragraph 9 of Regulation (EU) n� 528/2012
OR
Ammonium Acryloyldimethyltaurate/ VP Copolymer *
0,4 to 1 % by weight
OR
Carbomer neutralised with aminomethylpropanol (AMP) or with soda or with triethanolamin
0,2 to 1 % by weight
OR
Neutralised acrylate copolymer
1 to 3 % by weight
OR
Hydroxyethyl Acrylate/ Sodium Acryloyldimethyl Taurate Copolymer)
0,5 to 2 % by weight
OR
Acrylamide/ Sodium Acryloydimethyl Taurate & Isohexadecane & Polysorbate 80)
1 to 4 % by weight
OR
Acrylates/ C10-C30 alkyl acrylate crosspolymer
0,2 to 1 % by weight
MICROBIOLOGICALLY CLEAN DEIONISED WATER Q. S.
100 %
Batch release: immediate.
Other formulas and how to stay compliant after 31st May 2020
If you do not manufacture these formulas and/or do not fall under the type of companies described in the decree, this exemption does not affect you. You need to comply with regulation 528/2012 regarding the commercialisation of biocidal products, in France.
If you want to manufacture a hand sanitizer with ethanol as active substance, you must:
- Check that the ethanol provider is approved for this use.
- Carry out the poison centre notification: Synapse for France or ECHA�s platform starting on 1st January 2021
- Carry out the Simmbad notification for France (ethanol is still being evaluated)
- Have a compliant SDS under REACH and CLP regulations
- Have a compliant labelling under the biocides regulation n�528/2012
- Check the product�s compliance for topical use
In case of control by the authorities, compliant data on the products efficiency and for this use must be provided.
Be careful, if you do not use ethanol but use isopropanol and/or hydrogen peroxide, you must establish an MA (Marketing Authorisation) because these substances have already been approved under the biocidal regulation. Do not hesitate to contact our experts to know more on MA.
Usual rules for commercialising hand sanitizers
As a reminder, a hand sanitizer is a biocidal product destined to human hygiene (PT1) subject to the BPR EU n�528/2012.
As a consequence, the active substance.s (for sanitizers, alcohol) contained in the formula must be approved or under evaluation, but they must also come from an approved supplier. Moreover, the use being cutaneous, the formula must comply with the cosmetics regulation in order to guarantee maximum safety for the consumer when applied.
Depending on the status of the active substances contained in the product, the regulatory process varies, when putting hand sanitizers on the market. For more information on the matter, do not hesitate to take a look at our key concept on the biocidal MA or to contact our experts.
Wish to know more about biocidal products?
For more information, do not hesitate to contact Fang Zhou or one of our experts via our contact form, indicating the purpose of your inquiry.
