Biocides

Changes in Biocide-Related Regulations and Their Impact on the Paints Sector In recent years, increased sensitivity towards occupational health and safety as well as environmental issues have led to rapid changes in regulations, particularly those affecting chemicals. Keeping abreast of these changes and adapting to them has become an important matter for manufacturers in the paints and other sectors. One of the raw materials most affected by regulations is, as everyone knows, "preservatives" or alternatively "biocides". Preservatives are used in commercial products to prevent microbial degradation and the resulting economic losses, as well as potential environmental damage from disposal of spoiled products. Preservatives must first and foremost possess high efficacy. We can say that the primary objective of regulations is to ensure that preservatives fulfil this critical function with minimal risk to human and environmental health. The primary regulations concerning preservatives are those related to Biocidal Products. In the European Union, BPR 528/2012 aims to evaluate the active substances contained in biocidal products according to their applications in the relevant product types, and to ensure that only biocidal products containing approved actives are placed on the market. In Turkey, the Biocidal Products Regulation (BÜY) published on 31 December 2009 as part of harmonisation with the EU was updated on 21 December 2011, 12 March 2014, 12 March 2020, and most recently on 30 December 2021, continuing to establish procedures and principles regarding the production, import, licensing, packaging, labelling, classification, and inspection of biocidal products in Turkey prior to their placement on the market, in a manner that permits the assessment of risks to human, animal, and environmental health. The latest update published on 30 December 2021 introduced the following changes, among others: • Change in the definition of authorised laboratory: the definition is now limited to laboratories authorised solely to conduct biological efficacy analyses for pest control products in the 3rd main group (Article 4, paragraph 1, subsection aa). • Update of details of test methods serving as the basis for licensing (Article 6, paragraph 3). • Establishment of criteria concerning the laboratory in which tests will be conducted (Article 6, paragraphs 4-5-6). • Reference to ECHA guidance documents (Article 6, paragraph 7). • Removal of pre-application and sampling procedures (with the exception of 3rd group pest control products) (Articles 11, 18, and 19). • Update of label details and addition of QR code application (Article 36, paragraphs 8 and 9). • Inspection of licensed products on the market (Article 49, subsection f). Thanks to these changes, biocidal product manufacturers and importers have been afforded flexibility in having tests serving as the basis for licensing conducted at laboratories, whether abroad or in Turkey, provided that specified criteria are met, and clarification has been provided regarding test methods. Additionally, the process has been accelerated by removing pre-application and sampling procedures, and alignment with BPR in the EU has been targeted through reference to ECHA guidance documents. Another regulation closely concerning preservatives is Regulation (EC) 1272/2008 on "Classification, Labeling and Packaging" (CLP), which entered into force in the EU in 2009 and is based on the United Nations' Global Harmonised System (GHS). Its counterpart in Turkey, published on 11 December 2013 and known as "SEA", is the regulation on "Classification, Labelling and Packaging of Substances and Mixtures". The purpose of this regulation is to provide a high level of protection against adverse effects on human health and the environment that substances, mixtures, and certain articles placed on the market in Turkey may cause, in parallel with CLP, and to establish procedures and principles relating to their classification, labelling, and packaging. Within the scope of CLP regulation in the EU, updates are periodically published at specified intervals (Adaptation to Technical Progress: "ATP"). Most recently, the 17th ATP, set to enter into force on 17 December 2022, was published on 28 May 2021. In Turkey, the SEA regulation was updated on 10 December 2020 to cover the first 11th and 13th ATP in the EU. Under Transitional Provision 1, it was specified that the classification and labelling of products placed on the market before 1 January 2023 may be carried out in accordance with the provisions prior to the update. Within this scope, there will be differences between Turkey and Europe regarding the classification and labelling of certain substances and mixtures containing these substances. To summarise the classification changes in preservatives affecting the paints sector as a result of the updated SEA regulation: • Classification of Formaldehyde (CAS no. 50-00-0) as Carcinogenic Category 1 B (as it has been since 2016 under the 6th ATP published in the EU in 2014). • Addition of a specific concentration limit value of 15 ppm to the H 317 ("Causes allergic skin reactions") classification of Methylisothiazolinone (MIT, CAS no. 2682-20-4) (as it has been in effect since May 2020 under the 13th ATP published in the EU in 2018). Formaldehyde was already not being used since it was removed from the list of suitable active substances for in-can preservatives (PT 6) in Europe many years ago under the Biocidal Products Regulation, but formaldehyde donors are widely used in the paints sector in Turkey. However, usage in paints formulations in quantities that would require label changes is not anticipated. Methylisothiazolinone (MIT), which is used in combination with Benzisothiazolinone (BIT) due to synergistic efficacy, must be reviewed by the end of 2022 with regard to both its classification as a biocidal product and the classification and labelling of finished paint formulations containing it, and label updates must be made if necessary for products placed on the market from 1 January 2023 onwards. Where finished products containing Methylisothiazolinone (MIT) at 15 ppm or above would bear the H 317 hazard statement and exclamation mark on their labels, which would be undesirable from a consumer perspective, alternative preservatives must be tested and approved in terms of efficacy and long-term stability. On the other hand, within the scope of the 15th ATP published in the EU on 19 May 2020 and entering into force in March 2022, the following classification changes have occurred, but have not been included in the update content of the SEA in Turkey. • Addition of a specific concentration limit value of 15 ppm to the H 317 classification for Octylisothiazolinone (OIT, CAS no. 26530-20-1), • Addition of a specific concentration limit value of 15 ppm to the H 317 classification for DichloroOctylisothiazolinone (DCOIT, CAS no. 64359-81-5), • For Zinc Pyrithione (ZnPT, CAS no. 13463-41-7), the H 360 D classification (May damage the unborn child) and concentration limit value remain unchanged, but the aquatic acute and chronic M factors have been updated to 1000 and 10 respectively. The specific concentration limit value changes for OIT and DCOIT active substances are expected to result in the addition of the H 317 hazard statement and exclamation mark to labels on finished products containing these actives.   On the other hand, finished products containing Zinc Pyrithione (ZnPT) active substance at 250 ppm or above must bear the H 400 hazard statement ("Very toxic to aquatic life") and the "Environmental hazard" symbol (Dead fish and tree), which will create extra obligations regarding transport and packaging changes under the ADR regulation, potentially causing negative effects for the sector. Although the relevant regulation updates are not yet in force in Turkey, it is recommended that manufacturers pay particular attention to labelling when exporting to countries within the European Union, and if necessary, consult with experts on alternative biocide selection. Sources https://publications.europa.eu/resource/cellar/e3f31046-b274-11eb-8aca-01aa75ed71a1.0013.02/DOC_1 https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32020R1182&from=EN https://echa.europa.eu/regulations/biocidal-products-regulation/understanding-bpr Gül Öztoprak Regional Manager, Turkey Thor Specialties SRL