The BPR and the Pandemic: Towards a High Level of Human …... · 2020. 12. 9. · Article 82(3) of...

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9 December 2020

Koen Van Maldegem

The BPR and the Pandemic: Towards a High Level of Human Health Protection?

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1. The objectives of the BPR versus the Pandemic

2. Fast-track procedures?

i. Article 55(1) of the BPR

ii. Article 89(2) of the BPR

iii. Article 22 of Commission Regulation (EU) No 1062/2014

iv. Article 56 of the BPR (R&D)

3. Case studies: ethanol, citric acid; silver substances

4. Treated articles and claims

5. Borderline situations

6. Enforcement and sanctions

7. Conclusions

Summary


• Article 1: "The purpose of this Regulation is to improve the functioning of theinternal market through the harmonisation of the rules on the making available onthe market and the use of biocidal products, whilst ensuring a high level ofprotection of both human and animal health and the environment (…) "

• 10/3/2020: WHO declared COVID-19 a pandemic and worldwide biocides were usedto combat the virus.

• Almost a year later: what is the situation in Europe and what has the EU done toachieve:

– a harmonisation of the marketing and use of biocides, and

– a high level of protection for humans?

1. The Objectives of the BPR


• Article 55(1) of the BPR: "By way of derogation from Articles 17 and 19, a competent authoritymay permit, for a period not exceeding 180 days, the making available on the market or use ofa biocidal product which does not fulfil the conditions for authorisation laid down in theRegulation …"

• Applies to biocidal products containing:

i. active substances approved at EU level;

ii. active substances not in the review program (i.e., new substances, substances

reviewed/approved in a different PT and not approved substances).

• "For a limited and controlled use under the supervision of the competent authority, if such ameasure is necessary because of a danger to public health, animal health or the environmentwhich cannot be controlled by other means"

2. Fast-Track Procedures: Article 55(1) of the BPR


• National measure for periods up to 180 days. Extension possible? Only:

• upon reasoned request from a competent authority, and

• by means of a Commission implementing act, adopted under the examination procedure referred to inArticle 82(3) of the BPR, and

• for a period not exceeding 550 days.

• Article 55(1) of the BPR contains no derogation from Article 95 of the BPR => inclusion on theArticle 95 list of suppliers is still required.

Article 95(1): since 1/9/2015, substance or product suppliers must have access to a complete activesubstance dossier and be included on the list of approved sources drawn up by ECHA, failing which theyare excluded from the market;

but, technical equivalence is not a requirement for companies to be Article 95 listed.



• Article 89(2) of the BPR ("Transitional regime") applies to active substances that are in thereview program and for which no decision on approval has been taken (e.g., ethanol).

• National regimes apply: no harmonization.

• Not limited to 180 days.

• Article 95 of the BPR is part of the transitional rules => inclusion on the Article 95 list ofsuppliers is still required.

• Article 22 of Commission Regulation (EU) No 1062/2014: a Member State can within 18months from a non approval decision request a derogation, if it can show that:

• the substance is essential to prevent or control a serious danger to human or animal health or the environment, or

• not approving would have a disproportionate negative impact on society.



• Article 56 of the BPR ("Research and Development") allows for tests to be conducted involvingan unauthorized biocidal product or a non-approved active substance.

• Applies to product and process-oriented R&D (see definitions in REACH).

• Written records must be drawn up and maintained and a dossier compiled to be madeavailable to the competent authority upon request.

• In case of release into the environment, prior notification to the competent authority isneeded. If no reaction within 45 days, the test can take place.

• If immediate or delayed harmful effects on humans, animals or the environment are possible:

• the competent authority can prohibit the test or make it subject to conditions, and

• the competent authority must inform ECHA of its decision.

2. Fast-Track Procedures: Article 86 of the BPR (R&D)


• Lack of harmonization between Member States, especially relevant for PT1 (human hygiene)and PT2 (surface disinfection) substances.

• Most EU Member States apply Article 55(1) of the BPR, but

• not all do (see Greece, Romania – also Norway, Liechtenstein and Iceland);

• some invoke Article 55(1) wrongly (for example for ethanol – based products), and

• products are: WHO formulations, 1-Propanol, 2-Propanol, Hydrogen Peroxide based.

• National regimes under Article 89(2) of the BPR are a cacophony of very different measures:

• some Member States require substantive data (e.g., Belgium), others require little or no data (e.g. France and Germany);

• some grant authorisations case-by-case (Belgium) and others by decrees covering groups of products, and

• timings and 180 day periods are "freely interpreted and applied".

2. Fast-Track Procedures: Situation today


• Lack of harmonization between Member States as regards inclusion on the Article 95 List:

• Austria: Active substance can come from entities not on the Article 95 List, but they must comply with the quality criteriaset out in the exemption.

• Croatia: Active substance may be purchased from entities not listed on the Article 95 List.

• Denmark: Danish EPA must be informed and can derogate.

• Germany: BAuA guidance provides that Article 95 listing is not needed.

• UK: Reasonable efforts to source from an Article 95 company (HSE guidance).

• Most often, these derogations are motivated to facilitate market access (but strictly speakingthey are unlawful).

• Increases confusion for industry and users.

2. Fast-Track Procedures: Situation today


• Ethanol is of crucial importance to combat the COVID-19 pandemic.

• Draft CAR by Greece is available since May 2012; still no approval.

• Regulatory status is not harmonized.

• On 27 July 2020, Greece submitted an intention to propose a harmonizedclassification and labeling (CLH) as, e.g., a reproductive toxicant Cat.2.

• Cat 2 classification means, e.g.:

– replace use at the workplace and prevent exposure of workers and pregnant and breast-feeding women;

– prohibit the use in cosmetics (unless allowed for specific uses by SCCS);

– prohibit use in food contact materials.

• If RAC decides on a Cat 1B classification: exclusion criterion and use by general public prohibited.

3. Case Studies: Ethanol


• Substance is approved since 2016 in PT2(Commission Regulation (EU) No 2016/1938).

• 24-25 September 2020 CA: Proposal to include citric acid into Annex I (simplified authorization procedure).

• Explanatory memorandum: "Such inclusion would in particular reduce the administrative burden, facilitatethe placing on the EU market of biocidal products presenting lower concerns for human health (…) andpromote innovation for such products ".

• Inclusion in Category 6, Annex I: inclusion on the Article 95 list of suppliers is still required and dataprotection rules apply.

• Main advantages:

– Products containing citric acid will be subject to simplified autorisation (under Articles 25 and 26 of the BPR).

– Limited dataset (mainly efficacy, including storage stability and shelf-life data).

– Not specific to PTs.

– No mutual recognition procedures, but only prior notification for marketing in other Member States.

3. Case Studies: Citric Acid


• November 2019: silver zeolite, silver copper zeolite, silver sodium hydrogenZirconium phosphate were not approved in PTs 2 and 7.

• Commission Implementing Decisions: "sufficient efficacy has not beenDemonstrated" (albeit that innate efficacy of silver is a scientific fact).

• Political argumentation: EU wants industry to show that a biocide offers benefits to society.

• Legal Cases are pending: Case T-122/20.

• The technologies involved make it possible to treat surfaces (e.g., door handles, tables, conveyer belts) witha biocide and, as such, there is high customer demand to combat the pandemic.

• Article 22 of Commission Regulation (EU) No 1062/2014: a Member State can within 18 months from a nonapproval decision request a derogation, if it can show that:

• the substance is essential to prevent or control a serious danger to human or animal health or the environment, or• not approving would have a disproportionate negative impact on society.

3. Case Studies: Silver substances in PTs 2 and 7


• “Any substance, mixture or article which has been treated with, or intentionally incorporates, one or morebiocidal products” (Article 3(1)(l) of the BPR).

• The substantive labelling requirements of Article 58(3) BPR apply:

• if a biocidal claim is made for the article, or

• when "in relation to the active substance(s) concerned, having particular regard to the possibility of contact withhumans or the release to the environment, the conditions associated with the approval of the active substance(s) sorequire“.

• CA-Sept13-Doc.5.1.e: “a claim is a statement indicating or implying:

• either that the treated article has a certain degree of protection against unwanted organisms. In this case, a claim thusrefers to a biocidal property of the treated article.

• or that the treated article has a certain efficacy or action against unwanted organisms. In this case, a claim refers to abiocidal function of the treated article.”

• Typical example of claims: “Contains (a preservative …)”, or “Effective against viruses”, or “Handdisinfectant”, or “Surface disinfectant”, etc.

4. Treated Articles


• BUT: “a treated article that has a primary biocidal function shall be considered a biocidal product“ (Article3(1)(a) of the BPR).

• Primary = of first rank or importance compared with another function; this is to be clarified on a case-by-case basis (Article 3(3) BPR).

• Commission Implementing Decision (EU) No 2015/1985 on an anti-viral tissue impregnated with citric acid:

• “An anti-viral tissue impregnated with citric acid and placed on the marketwith the claim ‘kills 99,9% of cold & flu viruses in the tissue’ shall beconsidered as a biocidal product in accordance with Article 3(1)(a) (…)and shall fall within product-type 2”.

• Claims with public health relevance (e.g., offering protection against bacteria, viruses, fungi) deserve“greater level of scrutiny” and must be considered “together with all other individual properties andfunctions and the intended uses of the treated article”.

4. Treated Articles


• Not obvious and also impacted by political considerations.

• CA-May19-Doc.6.1 (Garments treated with permethrin): “(…) nowadays permethrin is found almosteverywhere in the environment and mass production and use of such garments, if they were to be consideredtreated articles, will only worsen the situation. Other two Member States concurred with this view and alsopointed out that the purpose of the regulation should be borne in mind, which is not to encourage anindiscriminate use of biocidal products. It emerged from the discussion that there are divergent views amongMember States (…)”.

• February 2020 “Fact sheet” by KemI (“Articles treated with biocides”): “A manufacturer who releases atreated article on the market and claims that it has certain biocidal properties must be able to prove suchclaims. Unless the product is of benefit and effective, it is unnecessary to take the risks to health and theenvironment which are often associated with biocides”.

• Quid face masks, gloves, tissues, wipes (etc.) with a claim against COVID-19?

4. Treated Articles


• “The Queen's designer launches incredible must-have antiviral gloves:The technology they use is a silver-based compound that is applied to thefabric in the mill as part of the finishing process“ (Hello Magazine 9/7/2020)

What about antiviral masks? Question was asked to several MemberStates in March 2020. Response: “interesting question”.

• CA-Sept20: “Enforcement issues: Protective masks containing biocidal active substances”.

• BAuA: “Diese Sichtweise ist derzeit nich europäisch harmonisiert (…) wir gehen in Deutschland derzeit davonaus, dass es sich bie den hier ausgerüsteten Waren in der Regel um behandelte Waren im Sinne von Artikel 3Absatz 1 Buchstabe I der Verordnung (EU) Nr 528/2012 handelt, die nur dann in den Verkehr gebrachtwarden dürfen, wenn sie den Anforderungen des Artikel 58 der Biozidverdordnung genügen”.

4. Treated Articles


• Hand sanitisers and gels: Commission “Guidance on the applicableLegislation for leave-on hand cleaners and hand disinfectants (gel,Solution, etc.)”

“When the main purpose is to cleanse the skin they are probablysubject to the Cosmetic Products Regulation.

If no main purpose is declared and such products contain an active substance and are marketed withany claims of biocidal activity or specific effects of reducing cross-contamination, they would probablybe subject to the Biocidal Products Regulation.”

• Claims like “hygienically clean” (or similar wording) could be considered biocidal; but when it refers to“personal hygiene” (products for cleaning and keeping the skin in good condition) it can be a cosmetic use.

• Biocidal claims are “antibacterial”, “antiviral”, “effective against coronavirus”, etc.

• Quid case-by-case assessment (Article 3(3) of the BPR)?



• Face Masks, gloves, etc.

• If intended to protect the wearer, these are normally considered aspersonal protective equipment (Regulation (EU) No 2016/425).

• If intended to protect the patient, (during surgical procedures andother medical settings), these are normally considered as medical devices(Regulation (EU) No 2017/745).

• In both cases, safety requirements and CE marking apply, but not a pre-marketing authorizationrequirements as is the case for biocidal products.

• However, the question regarding masks, gloves and other articles with an antiviral claim remains largelyunresolved.



• Members States are reporting an “extraordinary” high number of alerts regarding disinfectant products thatare unlawfully on their market.

• Enforcement activity will increase in the fall and sanctions are severe.

• For example Belgium: Law of 21 December 1998 on Product Standards.

Uncompliant products can be recalled from the market;

Sanctions range from imprisonment to penalties of up to 4,000,000 EURO;

Administrative sanctions.

• Industry should also be aware of:

– misleading advertising (Article 72 of the BPR), and

– unfair business-to-consumer commercial practices.

6. Enforcement and Sanctions


• The Pandemic has not made biocides “fashionable” again. (Political) focus remains on reducing biocides asmuch as possible.

• The BPR aims to protect humans (animals and the environment) against dangerous biocides, but not againstviruses.

• The lack of harmonization is striking and visible at all levels:

in the application of Article 55(1) of the BPR;

in the transitional measures taken under Article 89(2) of the BPR;

in the approaches towards treated articles, claims, borderline situations, etc.

• Industry is faced with an extraordinarily complicated jigsaw puzzle and barriers to enter the market.

• Increasing market demand and regulatory burdens/uncertainties, lead to illegal situations.

• Choice between “pragmatism” and “policing” the BPR and its implementing regulations.

7. Conclusions

Belgium | China | France | Germany | Ireland | Italy | Luxembourg | Netherlands | Spain | UK | US (Silicon Valley) | fieldfisher.com |

BelgiumBrussels

ChinaBeijingGuangzhouShanghai

FranceParis

GermanyDüsseldorfFrankfurt Hamburg Munich

IrelandDublin

ItalyBolognaMilanRomeTurinVenice

Luxembourg NetherlandsAmsterdam

SpainBarcelonaMadrid

USSiliconValley

UKBelfastBirminghamLondonManchester

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