SEA Regulation Updated

10.12.2020

"Regulation Amending the Classification, Labeling and Packaging of Substances and Mixtures" amending the "Regulation on Classification, Labeling and Packaging of Substances and Mixtures" (SEA Regulation) published in the Official Gazette dated 11/12/2013 and numbered 28848 Repeated 10/12 / It was published in the Official Gazette dated 2020 and numbered 31330 and entered into force. The update brings amendments to articles 5 to 13 of the European Union's 1272/2008 EC “Classification, Labeling and Packaging (CLP) of Substances and Mixtures (CLP) Regulation excluding article 12.

The changes that have been made:

- The phrase "harmful by inhalation" in the clause (c) of the first paragraph of Article 25 of the SEA Regulation on "Exceptions to labeling conditions" was corrected as "aspiration hazardous". By adding the paragraph (e) to the same Article of the Regulation, it brings exceptions in special cases to substances and mixtures classified as corrosive to metals but not as corrosive to skin and / or eyes, in accordance with the heading 1.3 of Annex-1.

- By adding the clause (ç) to the second paragraph of Article 36 of the SEA Regulation, the provision of "packaged" in accordance with the heading 3.3 of the third part of Annex-2 for liquid detergents placed on the market for consumer use in disposable soluble packaging.

- By adding the 5th paragraph to the 41st Article regulating the "Obligation to Notify" of the Regulation, an exemption has been made from the Classification and Labeling notification of the substances registered according to KKDIK Regulation.

- A new provision has been added to Article 45 of the Regulation under the title of "National Poison Center". Under this provision, companies that place mixtures classified as harmful in terms of human health and due to their physical or chemical properties are obliged to provide detailed information on the chemical composition and hazard properties of the mixture to the National Poison Center of the Ministry of Health. However, the Ministry of Health has been given the authority to determine how such information will be reported.

- Annex-7, Annex-8, Annex-9, Annex-10 and Annex-11 annexes of the Regulation have been abolished. Changes have also been made in the annexes of Annex-1, Annex-2, Annex-3, Annex-4, Annex-5, Annex-6 of the same Regulation.

- In accordance with the Article 25 of the SEA Regulation Regulating the Classification and Labeling of Hazardous Substances and Mixtures, subtitle 1.3.6 is added to the "Exceptions in the Special Conditions Labeling Conditions" in the heading 1.3 of Annex-1 and classified as corrosive for metals, but the skin is corrosive An exception is made to the use of the GHS05 hazard mark on the label of substances or mixtures in finished form and placed on the market for consumer use that are not classified as eye damage (Cat 1).

- According to Article 31 of the Regulation, 1.5. In the title of "Exceptions from Labeling and Packaging Conditions" 1.5.2.4 subtitle is added to a distributor or downstream user for scientific research and development or quality control analysis and for the purpose of scientific research and development or quality control analysis. There are exceptions from the label elements specified in the 19th article of this Regulation on the labels of the inner packages of substances and mixtures placed on the market to be marketed.

- Two new categories, Level A and Level B, were added to the hazard class for flammable gases in the 2.2 heading of Annex-1, in which the classification criteria and labeling elements for physical hazards are defined, and the classification criteria for these categories are Table 2.2. 2, label elements are defined in Table 2.2.3.

- The title of "Flammable Aerosols" in title 2.3 of Annex-1 has been changed to Aerosols. Aerosol Cat3 classification criteria and decision logic have been added to the 2.3.2.2 header and figure 2.3.1. The label features for this classification category have been added to the Table 2.3.1.

- Additional packaging rules have been defined for liquid detergents placed on the market for consumer use in disposable soluble packaging by adding the heading 3.3 to the "Special Rules on Packaging" of Annex-2, which regulates the "Rules on Labeling and Packaging of Certain Substances and Mixtures".

Annex-3 hazard statements list, Annex-4 precautionary statements list, and Annex-5 hazard signs are updated in the second column. Annex-6, Third Part of "Harmonized Classification and Labeling for Certain Hazardous Substances", Table 3 Harmonized classification and labeling list of hazardous substances. updates have been made. New items were added to the Table 3 list and the classification and labeling of the items on the list were updated.

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The regulation entered into force on the date of publication. With Provisional Article 1, the labeling and packaging of substances and mixtures placed on the market before 01/01/2023 can also be made in accordance with the provisions before the amendment until 1/1/2023.

No classification and labeling (S&E) notification was made for substances placed on the market within the scope of the SEA Regulation and classified as harmless. With the update made, according to the provision of Article 41 of the SEA Regulation, manufacturers or importers who place substances that are classified as harmless to the market according to the "Regulation on Registration, Evaluation, Authorization and Restriction of Chemicals" are required to make the relevant S&E notifications through the KKS system.

Article 44 / A added to the Regulation, the provision of Notification to the National Poison Center will come into force on 01/01/2025 and the way of giving information on the composition and hazard properties of the mixture will be determined by the Ministry of Health.

Liquid detergents placed on the market for consumer use in disposable soluble packaging must be packaged in accordance with the additional packaging rules specified in section 3 of Annex-2.

link: https://www.resmigazete.gov.tr/eskiler/2020/12/20201210M1-1.htm