Regulatory Updates

Distribution date: 21 August 2017

The Regulation nº 28, issued on Brazilian Official Gazette on 9 August 2017 (Instrução Normativa nº 28, publicada no Diário Oficial da União em 9 de agosto de 2017) approves the technical regulation regarding production and quality control of Tuberculin Purified Protein Derivative (PPD).

Products Covered: HS Code(s): 3002. Diagnostic tests. Tuberculin Purified Protein Derivative (PPD)

Regulation Type: Regular notification

Distribution date: 17 August 2017 | Final date for Comment: 10 October 2017

The notified Standard is applicable throughout national territory and covers all underwater occupational activities.

Products Covered: Diving equipment and personal protective equipment (90200003)

Regulation Type: Regular notification

Distribution date: 17 August 2017 | Final date for Comment: 16 October 2017

The notified draft Resolution establishes the requirements for the entry into Colombia of samples of plant material for laboratory physico-chemical analysis. It covers the following: Purpose; Scope; Definitions; Licence application requirements; Procedures for obtaining a licence; Technical verification visit; Issue, renewal and cancellation of and amendments to a licence; Requirements for the entry of samples into Colombia (packaging and labelling); Obligations; Prohibitions; Inspection at point of entry; Official control; Penalties; Annex; and Period of validity.

Products Covered: Plant material

Regulation Type: Regular notification

Distribution date: 17 August 2017 | Final date for Comment: 17 October 2017

The List of Maximum Levels for Various Chemical Contaminants in Foods currently specifies a maximum level (ML) of 200 parts per million (p.p.m.) total glycoalkaloids in potato tubers (fresh weight), with total glycoalkaloids specified as being the sum of alpha-solanine and alpha-chaconine. If potatoes contain TGA at a concentration above 200 p.p.m., they would be considered in violation of section 4(1) of the Food and Drugs Act. The existing ML for TGA in potato tubers was reviewed by Health Canada in 2014. The Department has confirmed that this ML continues to be health protective and is achievable when good agricultural, manufacturing and storage practices are followed. Health Canada is proposing to transfer the existing ML for TGA in potato tubers from the List of Maximum Levels for Various Chemical Contaminants in Foods to the regulatory List of Contaminants and Other Adulterating Substances in Foods, thereby removing this ML from the first list. It is the intention of Health Canada to modify Part 2 of the List of Contaminants and Other Adulterating Substances in Food by adding a new entry for TGA (column 1), potato tubers (column 2) and 200 p.p.m. (column 3).

Products Covered: Total glycoalkaloids (TGA) in potato tubers (ICS Code: 67.080)

Regulation Type: Regular notification

Distribution date: 09 August 2017 | Final date for Comment: 15 October 2017

Health Canada's Food Directorate completed a detailed safety assessment of two food additive submissions that together seek approval for the use of steviol glycosides as a sweetener in snack bars including, but not limited to granola bars, cereal bars, fibre bars, and protein isolate-based bars. Steviol glycoside is already permitted for use in Canada as a sweetener in assorted unstandardized foods. As no safety concerns were raised through Health Canada's assessment the Department has enabled the food additive use of steviol glycosides described in the information document below by updating the List of Permitted Sweeteners, effective 2 August 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 this food additive.

Products Covered: Steviol glycosides (ICS Code: 67.220.20)

Regulation Type: Regular notification

Distribution date: 08 August 2017 | Final date for Comment: 08 October 2017

This Draft Resolution provides for the classification in the priority category, of registration petitions, post-registration and prior consent in clinical research of medications. The criteria and procedures for framing an application for registration, post-registration and prior consent in clinical research for drugs in the priority category are stablished under the terms of this Resolution, according to public relevance, in order to guarantee or expand access to pharmaceutical assistance,. ANVISA may classify as priority the requests for registration and post-registration of medicines for sale under medical prescription, which are under risk of market shortages that have an impact on public health. Medications prioritized and registered according to the criteria of this Resolution should be marketed within a period of up to 120 days from the date of publication of the registration. New drugs in the priority category, as a result of the criteria established in this Resolution, will have a period of 30 days to submit the price proposal to ANVISA, counted from the first business day after the protocol of the priority petition.   The classification in the priority category should be done at the moment of the protocol of the petition (registration, post registration alteration and previous consent in clinical research), which will be the object of prioritization. The deadline for final decision regarding the analysis of registration and post-registration requests for medicines classified as priority will be: I - 120 days for applications for registration of medication; II - 60 days for post-registration requests. In order to apply the criteria set forth in this Resolution, the priority petition for registration, post-registration and prior consent in clinical drug research must be instructed with all documentation required by current legislation and regulations.

Products Covered: HS 30

Regulation Type: Regular notification

Distribution date: 08 August 2017 | Final date for Comment: 07 October 2017

Resolution No. 0003 - Approval of the "Manual on the registration of veterinary enterprises and products".

Products Covered: Veterinary products

Regulation Type: Regular notification

Distribution date: 07 August 2017 | Final date for Comment: 06 October 2017

This standard specifies the requirements and methods of sampling and test for polyethylene plastic materials for the manufacture of plastic items used in contact with foodstuffs, pharmaceuticals and drinking water. This standard does not cover requirements of a packaging media for a particular foodstuff and drinking water other than toxicological considerations.

Products Covered: Polyethylene.

Regulation Type: Regular notification

Distribution date: 07 August 2017 | Final date for Comment: 06 October 2017

This Draft Uganda Standard specifies the requirements and methods of sampling and test for polyvinyl chloride (PVC) and its copolymers for the manufacture of plastic items used in contact with foodstuffs, pharmaceuticals and drinking water.

Products Covered: Polyvinylchloride (PVC).

Regulation Type: Regular notification

Distribution date: 07 August 2017 | Final date for Comment: 06 October 2017

This Draft Uganda Standard specifies requirements, sampling and test methods for Ammonium Nitrate intended primarily for use in explosives. NOTE: The requirements of this standard should be read in conjunction with the Act of 1964 cap 309 and/or other applicable regulations.

Products Covered: Commercial blasting explosives, Ammonium Nitrate.

Regulation Type: Regular notification