Distribution date: 19 February 2016 | Final date for Comment: 19 April 2016

<span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-family:'Verdana','sans-serif';font-size:9pt;mso-bidi-font-size:11.0pt;mso-fareast-font-family:'?? ??';mso-fareast-theme-font:minor-fareast;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:EN-US;mso-bidi-language:AR-SA;">Ministry of Health and Labour and Welfare will revise </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;mso-bidi-font-size:11.0pt;mso-fareast-font-family:'?? ??';mso-fareast-theme-font:minor-fareast;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:JA;mso-bidi-language:AR-SA;mso-ascii-font-family:Verdana;mso-hansi-font-family:Verdana;">the posi</span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;mso-bidi-font-size:11.0pt;mso-fareast-font-family:'?? ??';mso-fareast-theme-font:minor-fareast;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:EN-US;mso-bidi-language:AR-SA;mso-ascii-font-family:Verdana;mso-hansi-font-family:Verdana;">tive list in the Standards for Cosmetics </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;mso-bidi-font-size:11.0pt;mso-fareast-font-family:'?? ??';mso-fareast-theme-font:minor-fareast;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:JA;mso-bidi-language:AR-SA;mso-ascii-font-family:Verdana;mso-hansi-font-family:Verdana;">u</span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;mso-bidi-font-size:11.0pt;mso-fareast-font-family:'?? ??';mso-fareast-theme-font:minor-fareast;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:EN-US;mso-bidi-language:AR-SA;mso-ascii-font-family:Verdana;mso-hansi-font-family:Verdana;">nder the provision of Article 4</span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;mso-bidi-font-size:11.0pt;mso-fareast-font-family:'?? ??';mso-fareast-theme-font:minor-fareast;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:JA;mso-bidi-language:AR-SA;mso-ascii-font-family:Verdana;mso-hansi-font-family:Verdana;">2</span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;mso-bidi-font-size:11.0pt;mso-fareast-font-family:'?? ??';mso-fareast-theme-font:minor-fareast;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:EN-US;mso-bidi-language:AR-SA;mso-ascii-font-family:Verdana;mso-hansi-font-family:Verdana;">, Paragraph 2 of the act on securing quality, efficacy and safety of pharmaceuticals, medical devices, regenerative and cellular therapy products, gene therapy products, and cosmetics.</span></span></span></span></span></span></span></span>

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

Regulation Type: Regular notification

Distribution date: 22 February 2016 | Final date for Comment: 22 April 2016

Directive (EU) 2015/2203 of the European Parliament and of the Council of 25 November 2015 on the approximation of the laws of the member States relating to caseins and caseinates intended for human consumption and repealing Council Directive 83/417/EEC provides clarity as regards the classification of certain substances in edible caseinates which are considered food additives. The provisions on food additives in Directive (EU) 2015/2203 should be reflected in Annex II to Regulation (EC) No 1333/2008 on food additives. Edible caseinates belong to dairy products. However, that group is not specified in. Therefore, a food category "Edible caseinates" should be established and the additives authorised in edible caseinates should be included with the respective conditions of use. The transfer will ensure legal clarity and does not introduce new uses of food additives.

Products Covered: Food additives

Regulation Type: Regular notification

Distribution date: 22 February 2016 | Final date for Comment: 22 April 2016

Directive (EU) 2015/2203 of the European Parliament and of the Council of 25 November 2015 on the approximation of the laws of the member States relating to caseins and caseinates intended for human consumption and repealing Council Directive 83/417/EEC provides clarity as regards the classification of certain substances in edible caseinates which are considered food additives. The provisions on food additives in Directive (EU) 2015/2203 should be reflected in Annex II to Regulation (EC) No 1333/2008 on food additives. Edible caseinates belong to dairy products. However, that group is not specified in. Therefore, a food category "Edible caseinates" should be established and the additives authorised in edible caseinates should be included with the respective conditions of use. The transfer will ensure legal clarity and does not introduce new uses of food additives.

Products Covered: Food additives

Regulation Type: Regular notification

Distribution date: 25 February 2016 | Final date for Comment: 03 May 2016

The Food and Drug Administration (FDA) is extending the comment period for the notice of filing. In the notice, FDA requested comments on a filed food additive petition, submitted by the Center for Science in the Public Interest, Natural Resources Defense Council, Center for Food Safety, Consumers Union, Improving Kids' Environment, Center for Environmental Health, Environmental Working Group, Environmental Defense Fund, and James Huff, proposing that the food additive regulations be amended to no longer authorize the use of seven listed synthetic flavoring food additives and to establish zero tolerances for the additives. FDA is taking this action in response to a request for an extension to allow interested persons additional time to submit comments. The notice of filing was published on 4 January 2016 (81 FR 42). Text is available at https://www.gpo.gov/fdsys/pkg/FR-2016-02-23/pdf/2016-03708.pdf.

Products Covered:

Regulation Type: Addendum to Regular Notification

Distribution date: 25 February 2016 | Final date for Comment: 03 May 2016

The Food and Drug Administration (FDA) is extending the comment period for the notice of filing. In the notice, FDA requested comments on a filed food additive petition, submitted by the Center for Science in the Public Interest, Natural Resources Defense Council, Center for Food Safety, Consumers Union, Improving Kids' Environment, Center for Environmental Health, Environmental Working Group, Environmental Defense Fund, and James Huff, proposing that the food additive regulations be amended to no longer authorize the use of seven listed synthetic flavoring food additives and to establish zero tolerances for the additives. FDA is taking this action in response to a request for an extension to allow interested persons additional time to submit comments. The notice of filing was published on 4 January 2016 (81 FR 42). Text is available at https://www.gpo.gov/fdsys/pkg/FR-2016-02-23/pdf/2016-03708.pdf.

Products Covered:

Regulation Type: Addendum to Regular Notification

Distribution date: 25 February 2016 | Final date for Comment: 04 May 2025

The Administrative Regulation No. 6/2014 "Lista de substâncias proibidas de usar nos géneros alimentícios" (List of Prohibited Substances for Use in Food) was published in 2014. To protect food safety, the government continues to strengthen food safety surveillance and renew relevant food safety standards. In accordance with local food monitoring data, it is decided to amend the abovementioned administrative regulation and to add two types of chemicals, Borax or Boric Acid and Sudan Dyes, to the "Lista de substâncias proibidas de usar nos géneros alimentícios" (List of prohibited substances for use in food). Therefore, the government has published the Administrative Regulation No. 3/2016 Alteração ao Regulamento Administrativo n.º 6/2014 (Lista de substâncias proibidas de usar nos géneros alimentícios)/ Amendment to Administrative Regulation No. 6/2014 (List of prohibited substances for use in food). The regulation is applicable to the entire food supply chain including food production, processing, preparation, packaging, transportation, import, export, transit, storage, sale, delivery, holding or displaying for sale, etc.

Products Covered: Food

Regulation Type: Regular notification

Distribution date: 25 February 2016 | Final date for Comment: 04 May 2025

The Administrative Regulation No. 6/2014 "Lista de substâncias proibidas de usar nos géneros alimentícios" (List of Prohibited Substances for Use in Food) was published in 2014. To protect food safety, the government continues to strengthen food safety surveillance and renew relevant food safety standards. In accordance with local food monitoring data, it is decided to amend the abovementioned administrative regulation and to add two types of chemicals, Borax or Boric Acid and Sudan Dyes, to the "Lista de substâncias proibidas de usar nos géneros alimentícios" (List of prohibited substances for use in food). Therefore, the government has published the Administrative Regulation No. 3/2016 Alteração ao Regulamento Administrativo n.º 6/2014 (Lista de substâncias proibidas de usar nos géneros alimentícios)/ Amendment to Administrative Regulation No. 6/2014 (List of prohibited substances for use in food). The regulation is applicable to the entire food supply chain including food production, processing, preparation, packaging, transportation, import, export, transit, storage, sale, delivery, holding or displaying for sale, etc.

Products Covered: Food

Regulation Type: Regular notification

Distribution date: 29 February 2016 | Final date for Comment: 29 April 2016

This standard establishes good hygienic practices for fish landing site where unloading activities of fish and shellfish are performed with one or more activities i.e. sorting, transferring, buying and selling and primary preparation. The purposes are to maintain proper quality and safety of fish and shellfish for human consumption or for further processing. For other management purposes such as environment shall be done properly according to the relevant laws and will not be addressed in this standard. Also, the following requirements for good hygienic practices for fish landing site are specified: 1. Establishment; 2. Equipment; 3. Personal hygiene; 4. Handling of fish and shellfish; 5. Water; 6. Ice; 7. Toilets; 8. Chemicals; 9. Cleaning and Pest Control; 10. Management of refuse and waste from fish and shellfish sorting and transferring.

Products Covered: Fresh fish and shellfish (ICS Code: 67.020)

Regulation Type: Regular notification

Distribution date: 29 February 2016 | Final date for Comment: 29 April 2016

This standard establishes good hygienic practices for fish landing site where unloading activities of fish and shellfish are performed with one or more activities i.e. sorting, transferring, buying and selling and primary preparation. The purposes are to maintain proper quality and safety of fish and shellfish for human consumption or for further processing. For other management purposes such as environment shall be done properly according to the relevant laws and will not be addressed in this standard. Also, the following requirements for good hygienic practices for fish landing site are specified: 1. Establishment; 2. Equipment; 3. Personal hygiene; 4. Handling of fish and shellfish; 5. Water; 6. Ice; 7. Toilets; 8. Chemicals; 9. Cleaning and Pest Control; 10. Management of refuse and waste from fish and shellfish sorting and transferring.

Products Covered: Fresh fish and shellfish (ICS Code: 67.020)

Regulation Type: Regular notification

Distribution date: 04 March 2016 | Final date for Comment: 04 May 2025

Products Covered: Prescription status of medicinal ingredients for human use (ICS: 11.120; HS: 3004.90)

Regulation Type: Addendum to Regular Notification