Unbelievable but true – due to the outbreak of COVID-19, hand and surface disinfectants are currently hardly available anywhere in the shops. Where they are made available – like in restaurants or hospitals – they mysteriously disappear. Pharmacies are therefore offering self-produced disinfectants at considerable prices.
Now, disinfectants regularly contain ethanol as the only active substance. And this is a substance that spirits manufacturers are very familiar with. The idea of expanding the business model a little thus naturally presents itself. But before entering the disinfectants business, it is important to consider the legal framework.
Hand and surface disinfectants are "biocidal products" as defined in Art. 3 (1) (a) of the Biocidal Products Regulation (EU) No. 528/2012 ("BPR"). In principle, every biocidal product requires approval and authorisation.
The approval is for the active substance contained in the biocidal product and is issued for a specific product type ("PT") depending on the intended use. As already mentioned, disinfectants regularly contain ethanol1 as the only active substance. In this case, the product types of the two "disinfectants" (main group 1) would be PT1: "human hygiene" and PT2: "disinfectants and algaecides not intended for direct application on humans or animals". These are products for the disinfection of surfaces, materials, equipment and furniture not used for direct contact with food or feedstuff.
The authorisation is for the final biocidal product and is issued to the distributor and the finished product (or product family).
Approval/authorisation requirements for ethanol
A complete approval and licensing procedure can easily take two years and cost several hundred thousand euros. Fortunately, there are certain exceptions and transitional periods. This is because ethanol is a so-called "old active substance" which has been used for many years as a PT1 and PT2 disinfectant. The substance is listed in Annex II of Delegated Regulation (EU) No. 2017/698 (amending Review Regulation (EU) No. 1062/2014) and is currently still in the so-called "review programme". This means that it is being examined at the European level whether ethanol should be approved as a biocidal active substance throughout the EU and for which PTs.
For such old (listed) active substances that are still in the review programme, Art. 89 et seq. BPR provides simplified transitional provisions. According to these provisions, old active substances can be placed on the market without approval, provided national regulations are observed. Under current Austrian law (Sec. 2 of the Biocidal Products Act, Federal Law Gazette I No. 105/2013, as amended), biocidal products containing (only) old active substances and whose approval for the respective product type has not yet been completed may be marketed in Austria without prior authorisation until the final completion of their review.
There is also no obligation to notify such biocidal products in Austria. This sounds very pleasing as an interim result. But there are a few more points to note:
From 1 September 2013, manufacturers and importers of active substances for biocidal products had to submit the following to the European Chemicals Agency ("ECHA"):
(a) a complete substance dossier; or
(b) a letter of access to a substance dossier; or
(c) a reference to a substance dossier referred to in point (a) for which all data protection periods have expired
The ECHA then published a list of the persons who submitted the relevant documents or in respect of whom it had taken a decision in accordance with Art. 63 (3) BPR. Listed companies may continue to distribute the registered active substances or use them in the manufacture of biocidal products.
If you do not want to produce the ethanol yourself, but purchase it from a listed manufacturer/importer, you can start mixing the disinfection products – subject to any national notification obligations and trade law hurdles.
If, however, you are not on this list and want to produce your own ethanol for a disinfectant, you must apply for registration according to Art. 95 BPR with the ECHA and wait for a decision before the biocidal product can be placed on the market. The three variants involve different amounts of time and costs:
1) Creation of a complete substance dossier ("dossier")
Such a dossier is time-consuming and costly. Manufacturers should expect at least one and a half to two years for the preparation and application and EUR 200,000 – 300,000 to start. The dossier must be submitted to and evaluated by the ECHA, for a fee of EUR 40,000.
2) Letter of access for a dossier
A "letter of access" is an original document signed by the owner of the data or his representative, which states that the data concerned on a biocidal active substance may be used by competent authorities, the Agency or the Commission for the purposes of this Regulation for the benefit of a third party (Art. 3 (1) (t) BPR). It may be purchased from an active substance manufacturer and authorisation holder for ethanol registered in the Art. 95 BPV list2. The price is not regulated by law. The parties must negotiate this contractually. However, the submission and handling fee must be paid to the ECHA and amounts to EUR 2,000, but the procedure is relatively quick. Ideally, production can begin within a few weeks.
3) Reference to a dossier
Submissions may also consist of a letter of access which does not cover all essential points or, where appropriate, a reference to data for which the data protection period has expired. Here, in addition to the access letter, further information must be submitted to the ECHA. If necessary, a decision must be obtained from the ECHA that the reference to the requested data is permitted under Art. 63 (3) BPR. The fee for submitting the document is EUR 20,000. The time component is difficult to estimate. The less additional information is required for the letter of access, the faster the application can of course be prepared.
The trade "production of chemical-technical products" (which are not to be classified as poisons within the meaning of Sec. 50 (4) of the Austrian Trade Law – GewO 1994), which would include a common hand/surface disinfectant, is a "free trade" in Austria.3 No certificate of competence or official authorisation is required to exercise the trade. However, the trade would still have to be reported to the competent district administrative authority before the activity may be commenced.
3. National list of free trades, Austrian Federal Ministry – Digital and Economic Affairs, as of 4 February 2020, available in German: https://www.bmdw.gv.at/dam/jcr:2b970ff0-8961-46ff-afcd-c1189ae10792/Bundeseinheitliche_Liste_der_freien_Gewerbe.pdf.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.