Regulatory Updates

Distribution date: 06 November 2014 | Final date for Comment: 05 January 2015

<span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-family:'Verdana','sans-serif';font-size:9pt;">This amendment&nbsp;includes provisions on additional chemical substances for cosmetics and contains revised provisions on existing substances. Furthermore, this revision is realized with the aim of aligning the "Regulation of Cosmetics" with the related EU Regulation "(EC) No 1223/2009 on cosmetic products of the European Parliament and the Council dated 30 November 2009 ".</span></span>

Products Covered: ESSENTIAL OILS AND RESINOIDS; PERFUMERY, COSMETIC OR TOILET PREPARATIONS (HS code(s): 33); Cosmetics. Toiletries (ICS code(s): 71.100.70)

Regulation Type: Revision to Regular Notification

Distribution date: 04 November 2014 | Final date for Comment: 10 January 2015

Health Canada's Food Directorate completed a detailed safety assessment of a food additive submission seeking approval for the use of silica (silicon dioxide) as a colour stabilizer in a number of permitted colouring agents. Silicon dioxide is already a permitted food additive in Canada. However, there are no food additive provisions for the use of silicon dioxide to stabilize colouring agents, either in the Lists of Permitted Food Additives or in the standards in Division 6 of the Food and Drug Regulations that set out specifications for colouring agents. As no safety concerns were raised through this assessment, the Department has enabled the food additive use described in the information document by modifying the List of Permitted Food Additives with Other Generally Accepted Uses, effective 28 October 2014. 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. Health Canada's Food Directorate is committed to reviewing any new scientific information on the safety in use of any food additive, including silicon dioxide. Anyone wishing to submit new scientific information on the use of this additive or to submit any inquiries may do so in writing, by regular mail or electronically.

Products Covered: Silicon Dioxide (ICS Code: 67.220.20)

Regulation Type: Regular notification

Distribution date: 04 November 2014 | Final date for Comment: 10 January 2015

Health Canada's Food Directorate completed a detailed safety assessment of a food additive submission seeking approval for the use of silica (silicon dioxide) as a colour stabilizer in a number of permitted colouring agents. Silicon dioxide is already a permitted food additive in Canada. However, there are no food additive provisions for the use of silicon dioxide to stabilize colouring agents, either in the Lists of Permitted Food Additives or in the standards in Division 6 of the Food and Drug Regulations that set out specifications for colouring agents. As no safety concerns were raised through this assessment, the Department has enabled the food additive use described in the information document by modifying the List of Permitted Food Additives with Other Generally Accepted Uses, effective 28 October 2014. 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. Health Canada's Food Directorate is committed to reviewing any new scientific information on the safety in use of any food additive, including silicon dioxide. Anyone wishing to submit new scientific information on the use of this additive or to submit any inquiries may do so in writing, by regular mail or electronically.

Products Covered: Silicon Dioxide (ICS Code: 67.220.20)

Regulation Type: Regular notification

Distribution date: 03 November 2014

The Food and Drug Administration (FDA) is announcing that we have filed a petition, submitted by Colorcon, Inc., proposing that the color additive regulations be amended to provide for the safe use of spirulina extract as a color additive in coating formulations applied to dietary supplement and drug tablets and capsules.

Products Covered: HS Code(s): 29, 30; ICS Code(s): 11. Dietary supplement and drug tablets and capsules.

Regulation Type: Regular notification

Distribution date: 03 November 2014

The Food and Drug Administration (FDA) is announcing that we have filed a petition, submitted by Colorcon, Inc., proposing that the color additive regulations be amended to provide for the safe use of spirulina extract as a color additive in coating formulations applied to dietary supplement and drug tablets and capsules.

Products Covered: HS Code(s): 29, 30; ICS Code(s): 11. Dietary supplement and drug tablets and capsules.

Regulation Type: Regular notification

Distribution date: 29 October 2014

The notified Technical Regulation covers the following: Purpose; Definitions, classification and designation; General conditions; Requirements; Analysis; Packaging and labelling; Storage and transport; and Appendix. ; ;

Products Covered: International Classification for Standards (ICS) code 67.120.20 ;

Regulation Type: Regular notification

Distribution date: 29 October 2014

The notified Technical Regulation covers the following: Purpose; Definitions, classification and designation; General conditions; Requirements; Analysis; Packaging and labelling; Storage and transport; and Appendix. ; ;

Products Covered: International Classification for Standards (ICS) code 67.120.20 ;

Regulation Type: Regular notification

Distribution date: 27 October 2014 | Final date for Comment: 26 December 2014

The notified draft Technical Regulation covers the following: Purpose; Scope; Definitions; Labelling requirements; Sampling; Reference documents; Conformity assessment procedure; Monitoring and inspection authority; Penalty regime; Liability of conformity assessment bodies; and Review and updating. ; ;

Products Covered: 38085000, 3808500011, 3808500019, 3808500021, 3808500029, 3808500031, 3808500039, 3808500090, 38089111, 38089112, 38089113, 38089119, 38089191, 38089192, 38089193, 38089194, 38089195, 38089196, 38089199, 38089211, 38089219, 38089291, 38089293, 38089294, 38089299, 38089311, 38089319, 38089391, 38089392, 38089399, 38089911, 38089919, 38089991, and 38089999. ;

Regulation Type: Regular notification

Distribution date: 27 October 2014 | Final date for Comment: 26 December 2014

The notified draft Technical Regulation covers the following: Purpose; Scope; Definitions; Labelling requirements; Sampling; Reference documents; Conformity assessment procedure; Monitoring and inspection authority; Penalty regime; Liability of conformity assessment bodies; and Review and updating. ; ;

Products Covered: 38085000, 3808500011, 3808500019, 3808500021, 3808500029, 3808500031, 3808500039, 3808500090, 38089111, 38089112, 38089113, 38089119, 38089191, 38089192, 38089193, 38089194, 38089195, 38089196, 38089199, 38089211, 38089219, 38089291, 38089293, 38089294, 38089299, 38089311, 38089319, 38089391, 38089392, 38089399, 38089911, 38089919, 38089991, and 38089999. ;

Regulation Type: Regular notification

Distribution date: 27 October 2014 | Final date for Comment: 26 December 2014

Proposed maximum residue limits (MRLs) for the following agricultural chemical Pesticide: Propiconazole

Products Covered: - Meat and edible meat offal (HS Code: 02.01, 02.02, 02.03, 02.04, 02.05, 02.06, 02.07, 02.08 and 02.09) - Dairy produce, birds' eggs and natural honey (HS Code: 04.01, 04.07 and 04.08) - Products of animal origin (HS Code: 05.04) - Edible vegetables and certain roots and tubers (HS Code: 07.01, 07.02, 07.03, 07.04, 07.05, 07.06, 07.07, 07.08, 07.09, 07.10, 07.13 and 07.14) - Edible fruits and nuts, peel of citrus/melons (HS Code: 08.01, 08.02, 08.03, 08.04, 08.05, 08.06, 08.07, 08.08, 08.09, 08.10, 08.11 and 08.14) - Coffee, tea, mate and spices (HS Code: 09.01, 09.02, 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10) - Cereals (HS Code: 10.01, 10.02, 10.03, 10.04, 10.05, 10.06, 10.07 and 10.08) - Oleaginous fruits, miscellaneous grains, seeds and fruits (HS Code: 12.01, 12.02, 12.04, 12.05, 12.06, 12.07, 12.10 and 12.12) - Animal or vegetable fats and oils (HS Code: 15.01, 15.02 and 15.06)

Regulation Type: Regular notification