Regulatory Updates

Distribution date: 09 April 2018 | Final date for Comment: 08 June 2018

The notified law seeks to: - Ensure pesticide quality control; - protect pesticide users; - protect consumers; - protect plants (treated and untreated), crops and stored products; - protect the environment; and - protect the interests of exporters.

Products Covered: Pesticides

Regulation Type: Regular notification

Distribution date: 04 April 2018 | Final date for Comment: 14 June 2018

The Concentration of Phosphorus in Certain Cleaning Products Regulations limit the amount of phosphorus in laundry detergents, household dish-washing compounds and certain household cleaners that are manufactured or imported into Canada. The proposed Amendments will exempt goods in transit through Canada to ensure Canada’s consistency with the World Trade Organization's (WTO) Agreement on Trade Facilitation (the Agreement). In addition, they would clarify that the concentration limit for phosphorus in household cleaning products does not apply to products used exclusively as metal cleaners or de-greasing compounds (the limits would still apply to household multifunctional cleaners); and standardize laboratory accreditation provisions with other regulations under the purview of Environment and Climate Change Canada (ECCC).

Products Covered: Cleaning products containing Phosphorus (HS Codes - 3401.19.0020; 3401.20.90; 3402.20.10; 3402.20.90; 3405.20; 3405.40)

Regulation Type: Regular notification

Distribution date: 03 April 2018 | Final date for Comment: 24 April 2018

Inclusion of strain CCT7766 of Paecilomyces lilacinus (Thom) Samson, exclusion of indication of cultures according to Act n. 6/2014, inclusion of use indicated in the package leaflet, exclusion of the indication of MRLs for the active ingredient P56 - PAECILOMYCES LILACINUS from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers.

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

Regulation Type: Regular notification

Distribution date: 03 April 2018 | Final date for Comment: 03 May 2018

The Minimum Requirements for Biological Products shall be partially amended to revise the standard for the “Rotavirus live attenuated, Oral, Pentavalent vaccine”.

Products Covered: PHARMACEUTICAL PRODUCTS (HS code(s): 30); (ICS code(s): 11.120)

Regulation Type: Regular notification

Distribution date: 29 March 2018 | Final date for Comment: 28 May 2018

1. Amendment of standards for scope, application and limitation of Potassium Sulfite, Sodium Sulfite, Sodium Sulfite (Anhydrous), Sodium Bisulfite, Sodium Hydrosulfite, Potassium Metabisulfite, Potassium Bisulfite and Sodium Metabisulfite;2. Establishment of standards for specification, scope, application and limitation of Sulfur Dioxide.

Products Covered: Food additives to be used in foods

Regulation Type: Regular notification

Distribution date: 28 March 2018

Products Covered: Brake and clutch fluid

Regulation Type: Addendum to Regular Notification

Distribution date: 28 March 2018 | Final date for Comment: 20 May 2018

Guiding on management of veterinary drugs.

Products Covered: All veterinary drugs

Regulation Type: Regular notification

Distribution date: 27 March 2018

Products Covered: Polyvinylchloride (PVC).

Regulation Type: Addendum to Regular Notification

Distribution date: 27 March 2018

Products Covered: Polyethylene.

Regulation Type: Addendum to Regular Notification

Distribution date: 27 March 2018 | Final date for Comment: 26 May 2018

The European Union has adopted two new regulations: one on medical devices, and the other on in-vitro diagnostic devices. It aims to improve the quality and safety of medical devices, to harmonize the implementation of legislation in the EU, and thereby increase the safety of patients. In the context of the partial revision of the Law on Therapeutic Products, the legislation relating to the regulation of medical devices has been redrafted and adapted to the new EU legislation. The partially revised law establishes, inter alia, the obligations for economic operators and the adapted requirements for medical devices, the conformity assessment procedure, and the registration and identification of products that must be brought into line with the corresponding EU provisions (the regulation on medical devices and the regulation on in-vitro diagnostic devices). In parallel, the legislation in force regarding medical devices has been reviewed in terms of existing measures, and adapted where necessary.

Products Covered: (HS code(s): 3002, 3003, 3004, 3006, 900130, 900140, 900150, 9003, 9004, 9018, 9019, 9020, 9021); (ICS code(s): 11.040, 11.040.60, 11.040.70, 11.120, 11.180)

Regulation Type: Regular notification