Regulatory Updates
Proyecto de Resolución del Instituto Colombiano Agropecuario - ICA "Por medio de la cual se prohíbe la importación, fabricación, registro, comercialización y uso de medicamentos veterinarios como productos terminados y aditivos empleados en la elaboración de alimentos para animales, que en su composición garantizada declaren contener como ingrediente el arsénico o compuestos arsenicales" (Draft Resolution of the Colombian Agricultural Institute (ICA) "Prohibiting the importation, manufacturing, registration, marketing and use of veterinary drugs as finished products and animal feed additives, the guaranteed composition of which includes arsenic and arsenic compounds".)
Distribution date: 13 November 2017 | Final date for Comment: 12 January 2018
The notified text establishes a prohibition on arsenic and arsenic compounds in animal feeds and veterinary drugs. Its articles refer to its objective and to reformulation, the time-limit for clearance of existing stocks, penalties, and the period of validity.
Products Covered: Veterinary drugs and animal feed.
Regulation Type: Regular notification
Listing of Colour Additives Exempt From Certification; Calcium Carbonate; Final Rule
Distribution date: 13 November 2017
The Food and Drug Administration (FDA or we) is amending the colour additive regulations to provide for the safe use of calcium carbonate to colour hard and soft candy, mints, and chewing gum. We are taking this action in response to a colour additive petition submitted by the Wm. Wrigley Jr. Company. The rule is effective 8 December 2017. The text is available at https://www.gpo.gov/fdsys/pkg/FR-2017-11-07/pdf/2017-24194.pdf
Products Covered:
Regulation Type: Addendum to Regular Notification
TITLE: Naturally-Occurring and Accelerator-Produced Radioactive Materials AGENCY: Nuclear Regulatory Commission ACTION: Petition for rulemaking; extension of comment period SUMMARY: On 23 August 2017, the U.S. Nuclear Regulatory Commission (NRC) requested public comment on a Petition for Rulemaking (PRM) received from Matthew McKinley on behalf of the Organization of Agreement States (OAS, or the Petitioner). The public comment period is scheduled to close on 6 November 2017. The NRC has decided to extend the public comment period for 30 calendar days to allow more time for members of the public to develop and submit their comments. DATES: The due date for comments requested in the Federal Register notice published on 23 August 2017, (82 FR 39971) is extended. Comments should be filed no later than 6 December 2017. Comments received after this date will be considered, if it is practical to do so, but the Commission is able to ensure consideration only for comments received on or before this date.
Distribution date: 13 November 2017
Products Covered: Radioactive materials
Regulation Type: Addendum to Regular Notification
DUS 1877: 2017, Deodorants and antiperspirants — Specification.
Distribution date: 09 November 2017 | Final date for Comment: 08 January 2018
This Draft Uganda Standard specifies the requirements, sampling and test methods for deodorants and antiperspirants. This standard does not apply to the medicated deodorants and antiperspirants, which claim therapeutic value.
Products Covered: Shaving preparations, incl. pre-shave and after-shave products, personal deodorants, bath and shower preparations, depilatories and other perfumery, toilet or cosmetic preparations, n.e.s.; prepared room deodorizers, whether or not perfumed or having disinfectant properties (HS code(s): 3307); Personal deodorants and antiperspirants (HS code(s): 330720); Cosmetics. Toiletries (ICS code(s): 71.100.70)
Regulation Type: Regular notification
DUS 1921: 2017, Body oils — Specification.
Distribution date: 09 November 2017 | Final date for Comment: 08 January 2018
This Draft Uganda Standard specifies the requirements, method of sampling and test for body oils based on refined vegetable oils or vegetable oils blends, mineral oils or mixture of the vegetable oils and mineral oils meant for application on the skin. It does not cover skin creams, lotions, hair oils and pure essential oils; and body oils for which therapeutic claims are made.
Products Covered: Body oils.
Regulation Type: Regular notification
Notice on Adjusting the Acceptance of Drug Registration (Draft)
Distribution date: 08 November 2017 | Final date for Comment: 07 January 2018
The adjustment to the acceptance of drug registration is: all the procedures shall now be handled by China Food and Drug Administration, instead of the former mode in which the application shall be accepted by provincial Food and Drug Administration, and be appraised and approved by China Food and Drug Administration.
Products Covered: Drugs ICS: 11.120.10 HS：30
Regulation Type: Regular notification
Projet de décret relatif à la sécurité sanitaire et la qualité du miel et des produits de la ruche commercialisés (Draft Decree on the safety and quality of honey and apicultural products available on the market)
Distribution date: 07 November 2017 | Final date for Comment: 06 January 2018
The notified draft Decree on the safety and quality of honey and apicultural products available on the market will provide Morocco with a regulatory text defining different types of honey and apicultural products and their physico-chemical characteristics. It has the following objectives: - To enable ONSSA control services to ensure the conformity of marketed or imported products; - To further motivate operators to produce high-quality honey and apicultural products and to create sector competitiveness to the benefit of consumers wanting these types of products; - To provide inspectors with a control tool enabling them to fulfil their task on the basis of national regulatory arguments. This regulatory tool will serve as a filter at border inspection points during the importation of honey and apicultural products; - To ensure consumers are informed of the origin of honey and apicultural products, whether locally produced or imported. Consumers are thus better informed to make better choices with regard to products on the market.
Products Covered: Miel
Regulation Type: Regular notification
Administrative Measures for Drug Standards (Draft)
Distribution date: 03 November 2017 | Final date for Comment: 02 January 2018
These measures are formulated to standardize the formulation, revision and release, as well as strengthen the implementation and supervision of drug standards. These measures consist of ten parts in accordance with the standard management workflow, i.e. general principles, programming, formulation and revision, approval and promulgation, implementation, review, information management and disclosure, supervision, local drug standards and supplementary rules .
Products Covered: Drugs HS:30 - ICS: 11.120.10
Regulation Type: Regular notification
Notice of Modification to the Lists of Permitted Food Additives to Extend the Use of (1) Citric Acid and Asparaginase from Aspergillus niger ASP72 to Blackstrap Molasses Destined for the Manufacture of Confectionery Glazes for Snack Foods and (2) Asparaginase from Aspergillus niger ASP72 to Green Coffee - Reference Number: NOM/ADM-0105
Distribution date: 01 November 2017 | Final date for Comment: 15 December 2017
Health Canada's Food Directorate completed a detailed safety assessment of a food additive submission seeking approval for the use of (1) asparaginase from Aspergillus niger (A. niger) ASP72 and citric acid in the manufacture of blackstrap molasses, and (2) asparaginase from A. niger ASP72 to treat green coffee. Asparaginase from A. niger ASP72 is already permitted for use as a food enzyme in various foods, and asparaginase from two other source organisms is already permitted for use to treat green coffee. Asparaginase has not previously been permitted for use in blackstrap molasses. Citric acid has numerous permitted food additive uses, but it has not previously been authorized for use in blackstrap molasses or any other standardized type of molasses. As no safety concerns were raised through Health Canada's assessment, the Department has enabled the requested uses of the food additives asparaginase from A. niger ASP72 and citric acid described in the information document below by updating the List of Permitted Food Enzymes (https://www.canada.ca/en/health-canada/services/food-nutrition/food-safety/food-additives/lists-permitted/5-enzymes.html) and the List of Permitted pH Adjusting Agents, Acid-Reacting Materials and Water Correcting Agents (https://www.canada.ca/en/health-canada/services/food-nutrition/food-safety/food-additives/lists-permitted/10-adjusting-agents.html), effective 2 October 2017. The purpose of this communication is to publically announce the Department's decision in this regard and to provide the appropriate contact information for any inquiries or for those wishing to submit any new scientific information relevant to the safety of these food additives.
Products Covered: Citric acid and asparaginase (ICS Code: 67.220.20)
Regulation Type: Regular notification
Partial amendment to the Minimum Requirements for Biological Products.
Distribution date: 31 October 2017 | Final date for Comment: 24 November 2017
The Minimum Requirements for Biological Products shall be partially amended to revise the standard for the “Recombinant Adsorbed Hepatitis B Vaccine (prepared from yeast)”.
Products Covered: Pharmaceutical Products (HS: 30)
Regulation Type: Regular notification
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