Non compliances noted by the DGCCRF
The DGCCRF (General Directorate for Competition, Consumer Affairs and Fraud Repression) published a press release on 18th November reminding the public of the importance of ensuring the effectiveness of hydroalcoholic solutions placed on the market.
The DGCCRF is one of the authorities responsible for checking the compliance and safety of products placed on the market in France, among which, hand sanitizers. These products experienced an extraordinary boom with the Covid-19 global pandemic. Today, many products are marketed but are not compliant with the European biocidal products regulation.
Out of the more than 180 products analysed, 38% were non-compliant. These products had incomplete or incorrect labelling. However, 35% of the products analysed were classified as non-compliant and dangerous. These products could have an insufficient amount of alcohol and thus be ineffective against Coronavirus (remember that a hand sanitizer must contain at least 60% alcohol to be effective). Other products minimised the dangers presented, in particular by not mentioning their flammable nature.
There are various problems, but the major problem is that consumers who think they are using a product that is effective against the virus easily risk being contaminated or infecting others.
Compliant biocidal products: where to start?
To bring your hydroalcoholic solutions into compliance, you need to comply with the European regulation on biocidal products, but not only!
- The composition must be compliant: the AS/PT couple (Active Substance/Product Type) must be approved or under evaluation by ECHA. In addition, in case of cutaneous application, compliance with the annexes of the cosmetic regulation is required
- The product must comply with Article 95: depending on the type of product, the supplier of the AS must be on the list of approved suppliers under Article 95
- The Safety Data Sheet (SDS): it must comply with the REACH and CLP regulations
- Labelling and packaging in accordance with BPR and CLP regulations
In addition, there are other steps to be taken which differ according to the type of AS:
- If the substance is under evaluation (as is the case for ethanol), the product is in a transitional period and it is not possible to obtain a Marketing Authorisation at EU level. Reference should be made to national measures. In the case of France, it is necessary to make a SIMMBAD declaration followed by a SYNAPSE declaration. In this case, the marketing period is less than one month. For disinfectants, there are 90 ASs under evaluation.
- If the AS has been approved (e.g. propanol), the product is in a perennial period and a Marketing Authorisation dossier must be submitted to ECHA, which can take several years. 39 ASs have already been approved for sanitizers and disinfectants.
To assist you in the compliance of all your biocidal products, do not hesitate to call on EcoMundo's experts. With a large number of biocidal products dossiers to their credit, they will be able to assist you in all your procedures thus preventing you from being subject to a product recall/withdrawal by the DGCCRF. We also invite you to watch our webinar replay on sanitizers and disinfectants.
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.
Non compliances noted by the DGCCRF
The DGCCRF (General Directorate for Competition, Consumer Affairs and Fraud Repression) published a press release on 18th November reminding the public of the importance of ensuring the effectiveness of hydroalcoholic solutions placed on the market.
The DGCCRF is one of the authorities responsible for checking the compliance and safety of products placed on the market in France, among which, hand sanitizers. These products experienced an extraordinary boom with the Covid-19 global pandemic. Today, many products are marketed but are not compliant with the European biocidal products regulation.
Out of the more than 180 products analysed, 38% were non-compliant. These products had incomplete or incorrect labelling. However, 35% of the products analysed were classified as non-compliant and dangerous. These products could have an insufficient amount of alcohol and thus be ineffective against Coronavirus (remember that a hand sanitizer must contain at least 60% alcohol to be effective). Other products minimised the dangers presented, in particular by not mentioning their flammable nature.
There are various problems, but the major problem is that consumers who think they are using a product that is effective against the virus easily risk being contaminated or infecting others.
Compliant biocidal products: where to start?
To bring your hydroalcoholic solutions into compliance, you need to comply with the European regulation on biocidal products, but not only!
- The composition must be compliant: the AS/PT couple (Active Substance/Product Type) must be approved or under evaluation by ECHA. In addition, in case of cutaneous application, compliance with the annexes of the cosmetic regulation is required
- The product must comply with Article 95: depending on the type of product, the supplier of the AS must be on the list of approved suppliers under Article 95
- The Safety Data Sheet (SDS): it must comply with the REACH and CLP regulations
- Labelling and packaging in accordance with BPR and CLP regulations
In addition, there are other steps to be taken which differ according to the type of AS:
- If the substance is under evaluation (as is the case for ethanol), the product is in a transitional period and it is not possible to obtain a Marketing Authorisation at EU level. Reference should be made to national measures. In the case of France, it is necessary to make a SIMMBAD declaration followed by a SYNAPSE declaration. In this case, the marketing period is less than one month. For disinfectants, there are 90 ASs under evaluation.
- If the AS has been approved (e.g. propanol), the product is in a perennial period and a Marketing Authorisation dossier must be submitted to ECHA, which can take several years. 39 ASs have already been approved for sanitizers and disinfectants.
To assist you in the compliance of all your biocidal products, do not hesitate to call on EcoMundo's experts. With a large number of biocidal products dossiers to their credit, they will be able to assist you in all your procedures thus preventing you from being subject to a product recall/withdrawal by the DGCCRF. We also invite you to watch our webinar replay on sanitizers and disinfectants.
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.
