Çarşamba, Temmuz 6, 2022

Regulation Updates Related to Biocides

Regulation Updates Related to Biocides and Their Effects on the Paint Industry

In recent years, regulations especially related to chemicals are changing very rapidly due to concerns about occupational health and safety as well as the environment. Following and keeping up with these changes has become an important issue for manufacturers in paint and other industries. “Preservatives”, or “biocides”, as predicted, are one group of chemicals mostly affected by regulations.

The biocides used to prevent microbial deterioration in commercial products and the economic losses that will result from it, as well as indirect possible environmental damage due to disposal of contaminated
commercial products, hence they must be very effective.

The target of regulations is mainly to make the biocides perform this critical and important task with minimum risk to human health and environment. Most important regulation related to biocides is the Biocidal Product Regulation, BPR 528/2012 in European Union that aim to assess the active substances in the biocidal products according to their application in the relevant product types and to regulate the launch of biocidal products in the market.

The Biocidal Products Regulation (BÜY) published in Turkey on 31.12.2009 within the scope of compliance with the EU was updated several times: on 21.12.2011, 12.03.2014, 12.03.2020 and finally on 30.12.2021.The aim of BÜY is to determine the procedures and principles regarding production, import licensing, packaging, labeling, classification
and supervision in order to assess the risks related to animal and environmental health, before biocidal products were placed to the Turkish market.

The last update published on 30.12.2021 has introduced following changes:
• Change of the definition of “authorized laboratory”, limiting the definition to laboratories
authorized to carry out efficacy tests of pest control products (3rd main group) only (Article 4, paragraph 1 aa).
• Updating the details of the test methods to be used for the license (Article 6, paragraph 3).
• Determination of the criteria for the laboratories where the tests will be carried out (Article 6 paragraphs 4-5-6).
• Reference of ECHA guide documents (Article 6, paragraph 7).
• Cancellation of pre-application and sampling procedures (except pest control products) (Article 11 – 18 – 19).
• Updating label details and adding a barcode (Article 36, paragraphs 8 and 9).
• Inspection of licensed products in the market (Article 49, paragraph f).

According to these changes, biocidal product manufacturers and importers were given the flexibility to carry out the tests in laboratories in Turkey or abroad, provided that they meet the specified criteria, test methods to be used were also clarified. Additionally, the process has been accelerated by cancelling preapplication and sampling procedures and harmonizing with BPR in EU is targeted with reference to ECHA guidance documents in the regulation text.

Regulation Updates Related to Biocides
Another regulation that is closely related to biocides is the “Classification, Labeling and Packaging” (CLP) regulation number 1272/2008, that is based on the Global Harmonization System of the United Nations (GHS), came into force in the EU in 2009. The counterpart is known as “SEA”, “Classification, Labeling and Packaging of Substances and Mixtures” published on 11.12.2013 in Turkey, where the purpose of the regulation is to provide a high level of protection against the negative effects of substances, mixtures and some treated articles introduced to the market in Turkey and to regulate the procedures and principles regarding classification, labeling and packaging in parallel with CLP.

Periodical updates (Adaptation to Technical Progress: “ATP”) are published in EU within the scope of CLP regulation. The last one was published on 28.05.2021, as the 17th ATP, which will be in force on 17.12.2022.

SEA regulation in Turkey was updated on 10.12.2020 to cover the first 11th ATP and 13th ATP in EU and it was stated under Provisional Article 1 that the classification and labeling of products to be introduced to the market before 01.01.2023 can be done according to the previous provisions.

In this context, there may be differences between Turkey and Europe regarding the classification and labeling of certain substances and mixtures containing those substances. We can summarize the classification changes about the biocides concerning the paint industry with the updated SEA regulation as following:

•Formaldehyde (Cas no 50-00-0) was classified as Carcinogenic Category 1 B (as in the EU since 2016 with the 6th ATP published in 2014).
• The new special concentration limit of 15 ppm for H 317 (“Causes allergic skin reactions”) classification was introduced to Methylisothiazolinone (MIT) (as it was published in 2018 with the 13th ATP and put in force as of May 2020 in EU).

Formaldehyde was not used directly as biocide, because it was removed from the list of active substances for incan preservatives (PT 6) within the scope of the Biocidal Products Regulation in Europe many years ago, but formaldehyde donors are widely used in the paint industry in Turkey. However, it is not expected that formaldehyde donors are used in
paint formulations at an amount that requires label change.

Formulations with Methylisothiazolinone (MIT) used in combination with Benzisothiazolinone (BIT) due to its synergistic effect and efficacy, needs to be reviewed by the end of 2022 and labels of final products may be revised from 01.01.2023. Alternative
biocides may be used for efficacy and long-term stability in cases where it is not favorable by the end user to have H 317 labeling and exclamation mark pictogram on the labels of finished products that contain 15 ppm or more Methylisothiazolinone (MIT).

On the other hand, the following changes on classification were made within the scope of the 15th ATP, which was published on 19.05.2020 in the EU and came into force in March 2022, but were not included in the updated SEA regulation in 2020.
• Introduction of 15 ppm special concentration limit for Octylisothiazolinone (OIT) (Cas no 26530-20-1) for H 317 classification and labeling,
• Introduction of 15 ppm special concentration limit for DichloroOctylisothiazolinone (DCOIT) (Cas no 64359-81-5) for H 317 classification and labeling,
• Classification of Zinc Pyrithione (ZnPT) (Cas no 13463-41-7) has not changed, still H 360 D (may cause damage to unborn child), however, acute and chronic aqu. M factors were updated as 1000 and 10 respectively.

Changes in the special concentration limits of OIT and DCOIT are likely to effect the label of finished products containing these actives and relabeling with H 317 and related pictogram.

Finished products containing 250 ppm or more of Zinc Pyrithione (ZnPT), which may be used both as film prevervative and as antibacterial/antiviral agent, will have hazard statement of H 400 (highly toxic in aquatic environment) and environmental hazard
(Dead fish and tree) pictogram, which can cause various problems for the paint industry as extra obligations on packaging and transportation will be imposed according to provisions of ADR.

Eventhough these provisions are not in force in Turkey, it is absolutely necessary to pay attention to labeling for exports to countries in European Union, if necessary consulting experts for alternative biocide selections.

https://publications.europa.eu/resource/cellar/e3f31046-b274-11eb-8aca 01aa75ed71a1.0013.02/DOC_1

Gül Öztoprak
Turkey Branch Manager
Thor Specialties SRL