Partial revision of the Japanese Pharmacopoeia, Seventeenth edition
Distribution date: 18 March 2019 | Final date for Comment: 17 May 2019
Under Article 41 of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices, the Japanese Pharmacopoeia, Seventeenth edition are to be revised.
Products Covered: Pharmaceutical Products (HS:30)
Regulation Type: Regular notification
Provisions for Imported Medicinal Materials (Revised Draft)
Distribution date: 18 March 2019 | Final date for Comment: 17 May 2019
The "Provisions for Imported Medicinal Materials" consists of 7 chapters and 43 articles. It is drafted in accordance with the import process of medicinal materials, including application and approval, registration, port inspection, supervision and management, etc. Measures as decentralizing approval authority, administrating by categories and traceability management are taken to facilitate applicants and strengthen the quality management of imported medicinal materials.
Products Covered: medicinal materials (HS: 05,06,09,12,13,30)
Regulation Type: Regular notification
Provisions for Imported Medicinal Materials (Revised Draft)
Distribution date: 18 March 2019 | Final date for Comment: 17 May 2019
The "Provisions for Imported Medicinal Materials" consists of 7 chapters and 43 articles. It is drafted in accordance with the import process of medicinal materials, including application and approval, registration, port inspection, supervision and management, etc. Measures as decentralizing approval authority, administrating by categories and traceability management are taken to facilitate applicants and strengthen the quality management of imported medicinal materials.
Products Covered: medicinal materials (HS: 05,06,09,12,13,30)
Regulation Type: Regular notification
Summary of the Revision of Pesticide Registration System
Distribution date: 20 March 2019 | Final date for Comment: 19 May 2019
To enhance safe use of pesticides, evaluation on pesticide operators and honeybees is to be introduced, and target species of animals and plants are added for environmental evaluation.
Products Covered: Agricultural chemicals (Pesticides) (HS Code:3808)
Regulation Type: Regular notification
Summary of the Revision of Pesticide Registration System
Distribution date: 20 March 2019 | Final date for Comment: 19 May 2019
To enhance safe use of pesticides, evaluation on pesticide operators and honeybees is to be introduced, and target species of animals and plants are added for environmental evaluation.
Products Covered: Agricultural chemicals (Pesticides) (HS Code:3808)
Regulation Type: Regular notification
TITLE: No Significant Risk Levels Section 25704 Exposures to Listed Chemicals in Coffee Posing No Significant Risk AGENCY: California Office of Environmental Health Hazard Assessment ACTION: Notice of Changes to Proposed Regulatory ActionSUMMARY: OEHHA has modified the language of proposed section 25704 to clarify the scope of listed chemicals covered by the proposed regulation. The modified language is in underline and strikeout format below: § 25704. Exposures to Listed Chemicals in Coffee Posing No Significant Risk Exposures to listed chemicals in coffee, listed on or before March 15, 2019 as known to the state to cause cancer, that are created by and inherent in the processes of roasting coffee beans or brewing coffee do not pose a significant risk of cancer. NOTE: Authority cited: Section 25249.12, Health and Safety Code. Reference: Sections 25249.6 and 25249.10, Health and Safety Code. OEHHA is requesting comments on the above−described modifications to the proposed regulatory text. There is no need to resubmit comments that were previously provided to OEHHA. In order to be considered, OEHHA must receive comments by 5:00 p.m. on 2 April 2019, the designated close of the comment period. Final Date for Comments: 2 April 2019 Proposed Adoption of New Section Under Article 7 No Significant Risk Levels Section 25704 Exposures to Listed Chemicals in Coffee Posing no Significant Risk: https://oehha.ca.gov/proposition-65/crnr/proposed-adoption-new-section-under-article-7-no-significant-risk-levels-0 No. 11-Z, California Regulatory Notice Register 15 March 2019 (page 445):https://oal.ca.gov/wp-content/uploads/sites/166/2019/03/11z-2019.pdf
Distribution date: 20 March 2019 | Final date for Comment: 30 April 2025
Products Covered: Coffee
Regulation Type: Addendum to Regular Notification
Summary of the Revision of Pesticide Registration System
Distribution date: 21 March 2019 | Final date for Comment: 20 May 2019
To enhance safe use of pesticides, evaluation on pesticide operators and honeybees is to be introduced, and target species of animals and plants are added for environmental evaluation.
Products Covered: Agricultural Chemicals (Pesticides) (HS:3808)
Regulation Type: Regular notification
TITLE: No Significant Risk Levels Section 25704 Exposures to Listed Chemicals in Coffee Posing No Significant Risk AGENCY: California Office of Environmental Health Hazard Assessment ACTION: Notice of Changes to Proposed Regulatory ActionSUMMARY: OEHHA has modified the language of proposed section 25704 to clarify the scope of listed chemicals covered by the proposed regulation. The modified language is in underline and strikeout format below: § 25704. Exposures to Listed Chemicals in Coffee Posing No Significant Risk Exposures to listed chemicals in coffee, listed on or before March 15, 2019 as known to the state to cause cancer, that are created by and inherent in the processes of roasting coffee beans or brewing coffee do not pose a significant risk of cancer. NOTE: Authority cited: Section 25249.12, Health and Safety Code. Reference: Sections 25249.6 and 25249.10, Health and Safety Code. OEHHA is requesting comments on the above−described modifications to the proposed regulatory text. There is no need to resubmit comments that were previously provided to OEHHA. In order to be considered, OEHHA must receive comments by 5:00 p.m. on 2 April 2019, the designated close of the comment period. Final Date for Comments: 2 April 2019 Proposed Adoption of New Section Under Article 7 No Significant Risk Levels Section 25704 Exposures to Listed Chemicals in Coffee Posing no Significant Risk: https://oehha.ca.gov/proposition-65/crnr/proposed-adoption-new-section-under-article-7-no-significant-risk-levels-0 No. 11-Z, California Regulatory Notice Register 15 March 2019 (page 445):https://oal.ca.gov/wp-content/uploads/sites/166/2019/03/11z-2019.pdf
Distribution date: 20 March 2019 | Final date for Comment: 30 April 2025
Products Covered: Coffee
Regulation Type: Addendum to Regular Notification
Guía Referencial para la Evaluación de Seguridad de Productos Cosméticos, para la Higiene Personal y Perfumes (Reference guide to safety assessment for cosmetic and personal hygiene products and perfumes) (14 pages, in Spanish)
Distribution date: 22 March 2019 | Final date for Comment: 30 April 2025
General guidance to help enterprises in the cosmetics sector select appropriate safety design mechanisms for cosmetic and personal hygiene products and perfumes, from the choice of ingredients to the final product, including appropriate label design so as to promote safe conditions of use. The Guide has been prepared on the basis of legislation currently in force.
Products Covered: Cosmetic and personal hygiene products and perfumes; essential oils and resinoids; perfumery, cosmetic or toilet preparations (HS 33); Cosmetics. Toiletries (ICS 71.100.70)
Regulation Type: Regular notification
Guía Referencial para la Evaluación de Seguridad de Productos Cosméticos, para la Higiene Personal y Perfumes (Reference guide to safety assessment for cosmetic and personal hygiene products and perfumes) (14 pages, in Spanish)
Distribution date: 22 March 2019 | Final date for Comment: 30 April 2025
General guidance to help enterprises in the cosmetics sector select appropriate safety design mechanisms for cosmetic and personal hygiene products and perfumes, from the choice of ingredients to the final product, including appropriate label design so as to promote safe conditions of use. The Guide has been prepared on the basis of legislation currently in force.
Products Covered: Cosmetic and personal hygiene products and perfumes; essential oils and resinoids; perfumery, cosmetic or toilet preparations (HS 33); Cosmetics. Toiletries (ICS 71.100.70)
Regulation Type: Regular notification
Submit your email ID to receive notifications about upcoming courses and events
