Regulatory Updates

Distribution date: 30 April 2018

Products Covered: Household products containing Methylene Chloride

Regulation Type: Corrigendum to Regular Notification

Distribution date: 27 April 2018 | Final date for Comment: 26 June 2018

The Ministry of Agriculture, Forestry and Fisheries (MAFF) will revoke designation of efrotomycin as feed additive since efrotomycin is no longer used, produced, imported or expected to be used in the future in/into Japan.

Products Covered: Efrotomycin as a feed additive

Regulation Type: Regular notification

Distribution date: 26 April 2018 | Final date for Comment: 30 June 2018

The Taiwan Food and Drug Administration (TFDA) is proposing an imported inspection requirement on egg products and dairy products importation. Importation of egg products for food purposes classified under four specific HS codes including 0407, 0408, 350211 and 350219, and dairy products for food purposes classified under seven specific HS codes including 0401, 0402, 0403, 0404, 0405, 0406 and 9806, shall be accompanied with official certificates individually noted for food purpose and in compliance with relevant food safety and sanitary regulations, and certificates shall be issued by the competent authority of the exporting country.

Products Covered: Egg products (HS Codes: 0407, 0408, 350211 and 350219) and dairy products (HS Codes: 0401, 0402, 0403, 0404, 0405, 0406 and 9806) for food purposes

Regulation Type: Regular notification

Distribution date: 26 April 2018

Technical Regulation amending Annex II of the SDA/SDC N° 02, 12 July 2013, that establishes the reference specifications for plant protection products approved for organic agriculture.

Products Covered: HS 38.08

Regulation Type: Regular notification

Distribution date: 23 April 2018 | Final date for Comment: 22 June 2018

The notified draft Resolution establishes the requirements and procedure for the registration with the ICA of cosmetics for veterinary use. The draft text covers the following: Purpose; Scope; Definitions; Registration of cosmetics for veterinary use; Requirements for the registration of cosmetics for veterinary use; Labelling; Review of registration requests; Procedures for issuing registration certificates; Issue of registration certificates; Amendments to registration; Obligations; Cancellation of registration; Authorization to import raw materials for the manufacturing of products exclusively for exportation; Other provisions; Advertising; Official control; Penalties; Transitional provision; and Period of validity.

Products Covered: Cosmetics for veterinary use

Regulation Type: Regular notification

Distribution date: 23 April 2018 | Final date for Comment: 22 June 2018

This Draft Uganda Standard prescribes the constructional, dimensional details, sampling and other particulars as a guideline to manufacturers of various types of T-shirts manufactured from 100% cotton yarn.

Products Covered: Cotton T-Shirts.

Regulation Type: Regular notification

Distribution date: 18 April 2018 | Final date for Comment: 17 June 2018

This draft of decree states that all of Paper and Paperboard for Food Packaging product produced within the country or imported, distributed and marketed in the country shall fulfil the SNI requirements. The producers which produced these products therefore shall comply with those requirements proven by having Product Certificate for Using SNI Mark. The product certificate on SNI marking shall be issued by a Product Certification Body which has been accredited by KAN and appointed by the Minister of Industry through testing of the conformity of the products quality against SNI requirements. Directorate of Forestry and Plantation Product Industries, Ministry of Industry is the institution that is responsible for the implementation of this decree and shall provide a technical guidance of the decree, which cover procedure of Product Certification and SNI Marking. Products which are distributed in domestic market that originated domestically and imported shall meet the requirements consisted in: SNI 8218:2015 Paper and Paperboard for Food Packaging — Safety requirementswhich specifies term and definition, quality requirements, sampling, testing method, testing acceptance, marking requirement and packaging (this standard is available in Indonesian).

Products Covered: SNI 8218:2015 Paper and paperboard for food packaging, consisted in Paper and paperboard of a kind used for making food packaging (HS 4804.39.20; 4804.42.10; 4804.49.10; 4804.52.10; 4804.59.10)

Regulation Type: Regular notification

Distribution date: 17 April 2018 | Final date for Comment: 16 June 2018

The proposed amendments seek to:1. Revise the recommended daily intake of Green tea extracts;2. Add new warning notices for the intake of Green tea extracts to the existing ones;3. Newly establish the warning notices for the intake of Aloe whole leaves, Garcinia cambogia extracts, and Probiotics; and4. Revise the manufacturing method of Probiotics.

Products Covered: Health functional food products

Regulation Type: Regular notification

Distribution date: 16 April 2018 | Final date for Comment: 24 April 2018

This Draft Resolution provides for toxicological information for labels and leaflets of pesticides, related products and wooden preservatives, within ANVISA. The guidelines for the preparation of toxicological information for labels and leaflets of pesticides, related products and wooden preservatives are approved within ANVISA. The purpose of this Resolution is to establish: I - the obligatory information related to the protection of human health that must be included in pesticide labels and leaflets, similar products and wooden preservatives; and II - the adoption of the labeling guidelines of the Globally Harmonized System of Classification and Labeling of Chemicals (GHS). The company is responsible for all labeling and package leaflet information, and must present it clearly and ensure that it is adequate and sufficient for health protection purposes. ANVISA may, at its discretion and with a reasoned technical justification, require the company that holds the record to change the texts of labels and package leaflets. The labels and package inserts of biological products and wooden preservatives must follow the provisions of this Resolution and the determinations provided in other specific devices and norms, and the necessary adaptations must be made to the peculiarities of the product. For information on appropriate poisoning prevention or risk minimization measures, the pictograms recommended by the Food and Agriculture Organization of the United Nations (FAO) should be used on pesticide labels and leaflets, as well as on wood preservatives. ANVISA may make available on the ANVISA website the latest version of the package leaflets and approved labels in relation to health information. Companies with already registered models of labels and pesticides, wood preservatives and preservatives must comply with this Resolution by means of a notification, with protocol under a specific subject code, and submit electronically to ANVISA all relevant documentation, up to 360 days after the validity of this Resolution, and may implement the labels and package inserts, without prior authorization from ANVISA.

Products Covered: ICS Code(s): 13, 65

Regulation Type: Regular notification

Distribution date: 16 April 2018 | Final date for Comment: 23 April 2018

This Draft Resolution establishes the criteria for the evaluation and toxicological classification of pesticides, components, related products and wooden preservatives, within ANVISA. The process of toxicological evaluation of products must be instructed with all the documentation established in Decree No. 4,074 of 4 January 2002, its updates or other specific legislation. The documentation required for the toxicological evaluation for product registration and post-registration shall be in accordance with specific legislation and standards. In order to instruct or justify the granting of registration to third parties, ANVISA may use data or information related to the results of studies submitted by another company. All toxicological studies submitted to comply with this Resolution shall be carried out in accordance with current protocols published by the Organization for Economic Co-operation and Development (OECD) or other authorities having similarity of requirements and validation. Without prejudice to the provisions of Decree No. 4,074 of 4 January 2002, for the studies of corrosion/skin irritation and ocular corrosion/irritation, the toxicological profile of a technical product is considered equivalent to the profile of the technical reference product, when does not fall into a category of greater danger, in accordance with specific legislation and in accordance with the equivalence criteria of the Food and Agriculture Organization of the United Nations (FAO). For purposes of toxicological classification, the criteria based on the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) are adopted in this Resolution. For pesticides, related and preservatives of wood already registered, the company must evaluate its toxicological dossier and verify the need for toxicological reclassification, considering the provisions of this Resolution. The company is responsible for evaluating the composition/formulation of its registered products and checking for the presence of unauthorized components.

Products Covered: Pesticides, components, related products and wooden preservatives; ICS Code(s): 13, 65

Regulation Type: Regular notification