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19.5.2020 11.30 Vierashuoneessa apulaisprofessori Stefan Kirchner: Biosidioikeus ja COVID-19 – Saksan ja EU:n näkymät

Vierashuoneessa apulaisprofessori Stefan Kirchner: Biosidioikeus ja COVID-19 – Saksan ja EU:n näkymät

COVID-19-pandemia johtaa vakaviin ihmisoikeusrajoituksiin kansanterveyden suojelemiseksi. Samanaikaisesti joitain oikeudellisia normeja heikennetään tehokkaan taudin torjunnan mahdollistamiseksi. Useissa maissa, myös Saksassa, desinfiointiaineiden tuotantoa koskevia säännöksiä on madallettu, jotta voidaan helpottaa SARS-CoV-2-viruksen tuhoamiseen tarvittavien desinfiointiaineiden tuotannon lisäämistä sekä yksityisissä ympäristöissä että terveydenhuollon laitoksissa. Jotkut säännöt ovat tarpeen sellaisten desinfiointiaineiden turvallisuuden ja laadun varmistamiseksi, joita nyt valmistavat myös yritykset, jotka saapuivat desinfiointiaineiden markkinoille vasta äskettäin. Korona-asiasta kirjoittaa apulaisprofessori Stefan Kirchner Edilexin Vierashuoneessa. 

Saksan liittovaltion työturvallisuus- ja työterveyslaitos hallinnoi tarvittavia tasapainotustoimenpiteitä desinfiointiaineiden saatavuuden ja markkinoille tulevien tuotteiden vaaditun laadun välillä antamalla yleisen määräyksen (Allgemeinverfügung), jolla hyväksytään biosidivalmisteet pinnan desinfiointiin (Allgemeinverfügung zur Zulassung Ethanol-haltiger, Chloramin-T-haltiger und Natriumhypochlorit-haltiger Biozidprodukte zur Flächendesinfektion zur Abgabe an und Verwendung durch berufsmäßige Verwender aufgrund einer Gefahr für die öffentliche Gesundheit). Sen sijaan, että tuottajia vaadittaisiin suorittamaan koko prosessi, mitä yleensä vaaditaan ennen desinfiointiaineiden pääsyä markkinoille, yleisen määräyksen tarkoituksena on hyväksyä markkinoille kaikki ammattimaisesti valmistetut desinfiointiaineet, jotka täyttävät tähän määräykseen sisältyvät vaatimukset. Tämä teksti johdattaa lukijaa yleiseen määräykseen, sen oikeudelliseen kehykseen ja sen vaatimuksiin. Tarkoituksena on antaa ammatinharjoittajille mahdollisuus hyödyntää parhaalla mahdollisella tavalla Saksan viranomaisten tarjoamia mahdollisuuksia kriisin aikana.

Summary: The COVID-19 pandemic is leading to severe restrictions of human rights for the purpose of protecting public health. At the same time, some legal norms are weakened in order to allow for an effective fight against the disease. In several countries, including in Germany, regulations on the production of disinfectants have been loosened in order to facilitate an increase in the production of disinfectants which are needed to destroy the SARS-CoV-2 virus, both in private settings and in health care institutions. In order to ensure the safety and quality of such disinfectants which are now being produced also by companies which only entered the disinfectant market only recently, some regulation is needed. The German Federal Institute for Occupational Safety and Health managed the necessary balancing act between ensuring the availability of disinfectants and the required quality of products entering the market by adopting a general decree (Allgemeinverfügung) admitting biocide products for surface disinfection (Allgemeinverfügung zur Zulassung Ethanol-haltiger, Chloramin-T-haltiger und Natriumhypochlorit-haltiger Biozidprodukte zur Flächendesinfektion zur Abgabe an und Verwendung durch berufsmäßige Verwender aufgrund einer Gefahr für die öffentliche Gesundheit). Rather than requiring producers to go through the entire process usually required before disinfectants are allowed to enter the market, the general decree has the effect of admitting to the market all professionally produced disinfectants which fulfil the requirements included in the general decree. This text introduces the reader to the general decree, the legal framework within which it is situated and its requirements, aiming to enable practitioners to make the best possible use of the opportunities afforded by the German authorities in this time of crisis.

1. Introduction

The COVID-19 pandemic has led to a dramatic increase in the demand of disinfectants, including surface disinfectants aimed at removing the SARS-CoV-2 virus in an effort to reduce the risk of infection. As the SARS-CoV-2 virus can remain active [1] on different surfaces for some time, there is a risk of transmission for example if the virus is placed on shared surfaces, such as door handles or handlebars in public transport. Surface disinfectants are particularly needed in environments where there is a high risk of transmission, for example in hospitals and in care homes. In a number of countries, including Finland, Spain, the United States and Germany, care homes have been the scenes of large-scale casualty events within the ongoing pandemic. This increasing need for disinfectants has to be met urgently. This need for urgency clashed with the general need to ensure that disinfectants which enter the market are of sufficient quality. 

2. Regulation (EU) No. 528/2012

a) Purpose

The latter need is met by the legal framework established by Regulation (EU) No. 528/2012 of the European Parliament and of the Council concerning the making available on the market and use of biocidal products. Based on the potential danger of biocidal products, such as disinfectants, [2] the Regulation establishes the conditions which have to be met before biocidal products may be brought to market in the European Union. [3] The Regulation’s purpose “is to improve the functioning of the internal market through the harmonisation of the rules on the making available on the market and the use of biocidal products, whilst ensuring a high level of protection of both human and animal health and the environment. The provisions of this Regulation are underpinned by the precautionary principle, the aim of which is to safeguard the health of humans, the health of animals and the environment. Particular attention shall be paid to the protection of vulnerable groups.” [4] The harmonisation of rules regarding the admission of biocidal products, such as disinfectants, allows authorities to simultaneously pursue multiple goals concerning the protection of public health and human safety, making safe disinfectants available across the European Union.

b) Authorization of biocidal products under Regulation (EU) No. 528/2012

Key regulations which are relevant for producers of biocidal products, such as disinfectants, prior to being “made available on the market” [5] are Articles 17, 19, 20, 22 and 25 et seq. of Regulation No. 528/2012. Article 17 para. 1 of the Regulation stipulates that “Biocidal products shall not be made available on the market or used unless authorised in accordance with this Regulation.” [6] The Regulation differentiates between two types of authorization procedures, national authorizations by the relevant national authorities [7] and Union authorizations by the European Chemicals Agency (ECHA), [8] which is based in Helsinki. Article 19 of the Regulation contains the conditions which need to be fulfilled before the relevant authorities may grant an authorization under the authorization procedure which is outlined in Articles 25 et seq. of the Regulation. The conditions included in Article 19 include, for example, the requirement that “it is established, according to the common principles for the evaluation of dossiers for biocidal products laid down in Annex VI, that the biocidal product, when used as authorised and having regard to the factors referred to in paragraph 2 of this Article, fulfils the following criteria: (i) the biocidal product is sufficiently effective; (ii) the biocidal product has no unacceptable effects on the target organisms, in particular unacceptable resistance or cross-resistance or unnecessary suffering and pain for vertebrates; (iii) the biocidal product has no immediate or delayed unacceptable effects itself, or as a result of its residues, on the health of humans, including that of vulnerable groups, or animals, directly or through drinking water, food, feed, air, or through other indirect effects; (iv) the biocidal product has no unacceptable effects itself, or as a result of its residues, on the environment, having particular regard to the following considerations: — the fate and distribution of the biocidal product in the environment, — contamination of surface waters (including estuarial and seawater), groundwater and drinking water, air and soil, taking into account locations distant from its use following long-range environmental transportation, — the impact of the biocidal product on non-target organisms, — the impact of the biocidal product on biodiversity and the ecosystem”. [9] In addition, Article 20 of the Regulation contains information concerning the formal requirements for such an application, while Article 22 outlines the content of the authorization, if one is granted.

c) Article 55 Regulation (EU) No. 528/2012

Article 55 of the Regulation allows EU member states to derogate from Articles 17 and 19. It is this possibility which allowed the German authorities, in particular the Federal Institute for Occupational Safety and Health (Bundesanstalt für Arbeitsschutz und Arbeitsmedizin), to take measures allowing a rapid increase in the amount of disinfectant which is made available in the current pandemic. According to Article 55, member states may “derogat[e] from Articles 17 and 19, [and consequently] a competent authority may permit, for a period not exceeding 180 days, the making available on the market or use of a biocidal product which does not fulfil the conditions for authorisation laid down in this Regulation, for a limited and controlled use under the supervision of the competent authority, if such a measure is necessary because of a danger to public health, animal health or the environment which cannot be contained by other means.” [10] While this possibility is primarily meant to allow biocidal products which rely on known active substances to enter the market, Article 55 (1) sentence 2 of the Regulation goes even further by stating that: “[b]y way of derogation from point (a) of Article 19(1) and until an active substance is approved, competent authorities and the Commission may authorise, for a period not exceeding three years, a biocidal product containing a new active substance. Such a provisional authorisation may be issued only if, after dossiers have been evaluated in accordance with Article 8, the evaluating competent authority has submitted a recommendation for approval of the new active substance and the competent authorities which received the application for the provisional authorisation or, in the case of a provisional Union authorisation, the Agency, consider that the biocidal product is expected to comply with points (b), (c) and (d) of Article 19(1) taking into account the factors set out in Article 19(2).” [11] That the European lawmaker is willing to take this risk is explained when one takes into account the purpose of this norm. Article 55 of the Regulation is made for situations like the one we experience today: a large-scale threat to public health which requires the rapid production and deployment of biocidal products, in this case, disinfectants.

3. The German Ordinance on the Admission of Biocide Products

It is against this backdrop that the current implementation of the German Ordinance on the admission of biocide products and other chemicals law procedures concerning biocide products and biocidal agents [12] has to be seen. The Ordinance applies to the admission, [13] or the lack of a need for an admission procedure, [14] the registration [15] and the testing [16] of biocidal products, as well as to the  recognition of foreign admissions of biocidal products [17] under the German Federal Chemicals Law. [18] These norms have become a hurdle in the fight against COVID-19 because the administrative procedures are too time consuming to allow for a rapid increase in the volume of disinfectant which can be brought to the market.

4. The general decree of 2 April 2020

This relevant federal authority aims to overcome this problem with the general decree of 2 April 2020. [19] Normally, the authorities tasked with ensuring the safety of biocidal products, would act through administrative acts (Verwaltungsakte) within the meaning of section 35 sentence 1 of the   Administrative Procedure Law [20] (Verwaltungsverfahrensgesetz [21] ). In this case, though, the Federal Institute for Occupational Safety and Health decided to use the other option afforded by section 35 Verwaltungsverfahrensgesetz through the issuance of a general decree (Allgemeinverfügung) according to section 35 sentence 2 Verwaltungsverfahrensgesetz. Rather than to suspend existing norms, such as the Ordinance or the Chemicals Law, the German federal administration utilized an existing and time-tested method, general decrees. While an administrative act is aimed at a determined number of addressees, a general decree addresses an unknown number of natural or legal persons. Traffic signs are classical examples for general decrees within the meaning of section 35 Verwaltungsverfahrensgesetz. By using this tool, the federal administrative body in charge of biocidal products, including disinfectants, created immediate legal effects, allowing everybody to engage in the production and marketing of surface disinfectants, as long as these meet the requirements outlined in part 2 of the general decree. This decree is based on Article 55 para. 1 of the aforementioned EU Regulation as Germany has derogated from the regular requirements for the admission to the market for biocidal products outlined above. The general decree of 2 April 2020 serves as such an admission to the market for such products. [22]

The general decree covers three types of biocidal products and imposes a number of general conditions: 80% v/v (volume for volume) ethanol in aqueous solution or 0.5 % sodium hypochlorite w/w (weight for weight) in aqueous solution or 2.5 % w/w chloramine-T in aqueous solution or

mixtures which contain these ingredients and which have been proven to be effective and which have been admitted in accordance with Regulation (EU) No. 528/2012 or which an application has been made on time in accordance with Article 89 para. 3 of said regulation [23] by pharmaceutical companies, [24] pharmacies [25] or legal persons of a public law nature in Germany. [26]

Ethanol must have a purity of at least 96 % v/v and has to be free from dangerous pollutants. [27] The purity has to be documented. [28] Such ethanol disinfectants may be used for surfaces of no more than two square meters [29] and have to remain on the surface for 15 minutes. [30] If pure alcohol, as produced by distilleries, is used, it has to contain at least 80 % pure alcohol [31] and the disinfectant produced by using it has to contain at least 80 % ethanol. [32] The purity of sodium hydrochlorite has to comply with Regulation (EU) 2017/1273. [33] Sodium hydrochlorite may only be used against enveloped viruses (such as SARS-CoV-2) [34] and may only be used on clean surfaces. [35] It has to remain on the surface for at least 30 minutes. [36] Similarly, chloramine-T has to have a purity of 98% (w/w) [37] and must be free of harmful pollutants. [38] The contact time for chloramine-T is at least 120 minutes. [39] In any case may the biocidal products may only be used for surface disinfection [40] and the information requirements contained in Regulation (EU) No. 528/2012 have to be met both on the packaging and in the information leaflet provided with the product. [41]

5. Concluding remarks

In line with the time limit included in Article 55 of the Regulation, the general decree automatically stops being applicable on 30 September 2020. Until then, this measure enables professional producers, such as pharmacies or distilleries, to produce the aforementioned biocidal products. In this way, using well-known legal tools, staying within the framework of EU law and striking a balance between the needs for disinfectants and product safety, the authorities have quietly, but only temporarily, shifted the approach concerning the market access of disinfectants. For the time being, the relevant supervisory authority in Germany refrains from checks prior to a product entering the market and instead trust professional producers to make precisely defined biocidal products available quickly and in a safe manner. In this way, the  administration enables the private sector to provide the tools needed to fight the COVID-19 pandemic, as befitting a market economy which is concerned not merely with short term profits and tax income but also with the welfare of residents, including the protection of public health.

Stefan Kirchner
Apulaisprofessori, Arktinen keskus, Lapin yliopisto, Rovaniemi

 

[1] The phrase “remain active” has been used here in order to avoid the phrase “stay alive” as a virus is not, strictly speaking, a living organism, because it is incapable of reproducing on its own, without a host organism.

[2] Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products , (hereinafter: “Regulation (EU) No. 528/2012” or “the Regulation”), Official Journal 2012 L 167/1, https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32012R0528&from=DE (all websites last visited 30 April 2020), Recital 1.

[3] Regulation (EU) No. 528/2012, Recital 2.

[4] Regulation (EU) No. 528/2012, Article 1.

[5] Regulation (EU) No. 528/2012, Article 17 (1). The phrase “made available on the market” is defined in Article 3 (1) (i) of the same Regulation as covering “any supply of a biocidal product or of a treated article for distribution or use in the course of a commercial activity, whether in return for payment or free of charge”. This is to be contrasted with “placing on the market”, which is defined in Article 3 (1) (j) as “the first making available on the market of a biocidal product or of a treated article” (italics added).

[6] Regulation (EU) No. 528/2012, Article 17 (1).

[7] Regulation (EU) No. 528/2012, Article 17 (2) sentence 2.

[8] Regulation (EU) No. 528/2012, Article 17 (2) sentence 3 and Article 3 (1) (x).

[9] Regulation (EU) No. 528/2012, Article 19 (1) (b) (i)-(iv).

[10] Regulation (EU) No. 528/2012, Article 55 (1) sentence 1.

[11] Regulation (EU) No. 528/2012, Article 55 (1) sentence 2.

[12] Verordnung über die Zulassung von Biozid-Produkten und sonstige chemikalienrechtliche Verfahren zu Biozid-Produkten und Biozid-Wirkstoffen (Biozid-Zulassungsverordnung - ChemBiozidZulV) [Ordinance on the admission of biocidal products and other chemical law procedures on biocidal products and biocidal agents], 4 July 2002, changed on 22 August 2006 (hereinafter: “the Ordinance” or “German Biocide Ordinance”), http://www.gesetze-im-internet.de/chembiozidzulv/ChemBiozidZulV.pdf.

[13] German Biocide Ordinance, Section 1, no. 1.

[14] German Biocide Ordinance, Section 1, no. 2

[15] German Biocide Ordinance, Section 1, no. 3.

[16] German Biocide Ordinance, Section 1, no. 5.

[17] German Biocide Ordinance, Section 1, no. 4.

[18] Gesetz zum Schutz vor gefährlichen Stoffen (Chemikaliengesetz - ChemG) [Law for the protection against dangerous substances],16 September 1980, reissued 28 August 2013, last changed 12 December 2019 (hereinafter: “Chemicals Law”), https://www.gesetze-im-internet.de/chemg/ChemG.pdf.

[19] Allgemeinverfügung zur Zulassung Ethanol-haltiger, Chloramin-T-haltiger und Natriumhypochlorit-haltiger Biozidprodukte zur Flächendesinfektion zur Abgabe an und Verwendung durch berufsmäßige Verwender aufgrund einer Gefahr für die öffentliche Gesundheit [General decree on the admission of biocidal products containing ethanol, chloramine-T and sodium hypochlorite for surfave desinfection to AGBANE and use by professional users due to a threat to public health] (hereinafter: “General Decreee”), 2 April 2020, https://www.baua.de/DE/Angebote/Aktuelles/Meldungen/2020/pdf/Allgemeinverfuegung-Oberflaechen.pdf?__blob=publicationFile&v=3.

[20] Verwaltungsverfahrensgesetz (Administrative Procedures Law), 25 May 1976, reissued 23 January 2003, last changed 21 June 2019, https://www.gesetze-im-internet.de/vwvfg/VwVfG.pdf.

[21] Note that the federal Verwaltungsverfahrensgesetz applies to administrative procedures in federal authorities. The administrative authorities of Germany’s sixteen federal states, the Länder, are covered by the parallel norms of the state’s Verwaltungsverfahrensgesetze, many of which mirror the federal Verwaltungsverfahrensgesetz or make explicit reference to it. The practical effect of the differences between the federal Verwaltungsverfahrensgesetz and those of the Länder are limited.

[22] General decree, part 3.

[23] General decree, part 2.

[24] Ibid.

[25] Ibid.

[26] Ibid.

[27] General decree, part 2, there footnote 3, no. 1.

[28] Ibid.

[29] General decree, part 2.

[30] General decree, part 2, there footnote 3, no. 1.

[31] General decree, part 2, there footnote 3, no. 2.

[32] Ibid.

[33] General decree, part 2, there footnote 5.

[34] General decree, part 2, there footnote 6.

[35] Ibid.

[36] Ibid.

[37] General decree, part 2, there footnote 7.

[38] Ibid.

[39] General decree, part 2, there footnote 8.

[40] General decree, part 2.

[41] General decree, part. 4.

Toimittaja: Jukka Savolainen, Edilex-toimitus (jukka.savolainen@edita.fi)

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