Regulatory Updates
Draft Commission Implementing Decision on the identification of 1,7,7-trimethyl-3-(phenylmethylene) bicyclo[2.2.1]heptan-2-one (3-benzylidene camphor) as a substance of very high concern pursuant to Article 57(f) of Regulation (EC) No 1907/2006 of the European Parliament and of the Council (4 pages, in English)
Distribution date: 29 January 2018 | Final date for Comment: 30 March 2018
This draft Commission Decision aims at identifying 3-benzylidene camphor as a substance of very high concern due to its endocrine disrupting properties whose effects to the environment give rise to an equivalent level of concern according to Article 57(f) of Regulation (EC) No 1907/2006 (REACH).
Products Covered: Chemical substance 1,7,7-trimethyl-3-(phenylmethylene)bicyclo[2.2.1]heptan-2-one (3-benzylidene camphor) (EC No. 239-139-9, CAS No. 15087-24-8, HS code 291439)
Regulation Type: Regular notification
Turkish Food Codex Communiqué Edible Caseins and Caseinates
Distribution date: 26 January 2018 | Final date for Comment: 27 March 2018
This draft is related to preparation, processing, labeling, preservation, storage, transport, market supply and product characteristics of the edible caseins and caseinates for human consumption in accordance with the technique and hygienic reguirements.
Products Covered: Caseins and caseinates which are intended for human consumption and mixtures thereof
Regulation Type: Regular notification
Pharmacists' Regulations (Cosmetics) 5778-2018 The draft regulations, notified in G/TBT/N/ISR/709/Add.1, dated 7 June 2017, have been amended and replaced by the Israel Ministry of Health, following comments submitted by WTO member states. The full text of the revised regulations (Hebrew only) is available online at:
Distribution date: 23 January 2018
Products Covered: Cosmetics (HS: Chapter 33; ICS: 71.100.70).
Regulation Type: Addendum to Regular Notification
This addendum aims at informing that the National Institute of Metrology, Quality and Technology – INMETRO and the Ministry of Environment are proposing to give trading partners an opportunity to provide comments and suggestions in relation to the Draft Bill establishing maximum limit of lead in paints and materials similar to Surface coating, elaborated in the category of the National Commission Chemical Safety Agency (CONASQ), with a coordination of the Ministry of the Environment (Ministério do Meio Ambiente-MMA). The comments should be forwarded exclusively through the electronic form available at www.mma.gov.br until 4 March 2018. Due to an IT incident we are looking forward to receiving the previously sent comments again. The full text is available in Portuguese and can be downloaded at:
Distribution date: 23 January 2018
Products Covered: HS-Chapter 32 - paints
Regulation Type: Addendum to Regular Notification
Regulation for Supervision and Administration of Internet Drug Trading (Draft)
Distribution date: 18 January 2018 | Final date for Comment: 19 March 2018
This regulation is formulated in order to strengthen the supervision and administration of internet drug trading, standardize the behavior of internet drug trading and ensure the safety of public drug use. There are six chapters and fifty-seven articles in this regulation, including general principles, administration of internet drug sale, administration of internet drug transaction service platform, supervision and administration, legal liability and supplementary provisions.
Products Covered: Drugs ICS: 11.120.10. HS: 30
Regulation Type: Regular notification
Good Data and Record Management Practices (Draft)
Distribution date: 18 January 2018 | Final date for Comment: 19 March 2018
Good Data and Record Management Practices (GDRP) include general provisions, quality management, personnel, basic requirements of data, system and supplementary provisions, which is applicable to drug development, manufacture, distribution, post-marketing surveillance and evaluation The data in GDRP should be complete as well as attributable, legible, contemporaneous, original and accurate, commonly referred to as "ALCOA".
Products Covered: Drugs ICS: 11.120.10 HS: 30
Regulation Type: Regular notification
Provisions for Overseas Inspection of Drugs and Medical Devices (Draft)
Distribution date: 18 January 2018 | Final date for Comment: 19 March 2018
Provisions for Overseas Inspection of Drugs and Medical Devices is applicable to the overseas development and production inspection of drugs and medical devices which are already on the market or will be on the market in China. The provisions consist of 5 chapters and 35 articles. 5 Chapters including general provisions, determination of the inspection task, inspection, audit and processing, and supplementary articles. The provisions specify the initiation, inspection and follow-up treatment of overseas drug and medical device inspection.
Products Covered: Drug ICS: 11.120.10 HS: 30 Medical device ICS: 11 HS: 9018, 9019, 9020, 9021, 9022
Regulation Type: Regular notification
Announcement for Adjustment of Review and Approval Process of Drug Clinical Study (Draft)
Distribution date: 18 January 2018 | Final date for Comment: 19 March 2018
This announcement is formulated by reference to international advanced experience, which aims to optimize the review process of drug clinical study, strengthen the communication with applicants, and enhance the review quality and efficiency of drug clinical study. This announcement consists of four parts according to the review process of drug clinical study, including preparation and application of communication meeting, convening of the communication meeting, acceptance, review and approval of drug clinical study application and other related items. In addition, the announcement has three annexes, i.e. application form of communication meeting, requirement for materials of communication meeting and requirement for application of dossier of phase I clinical study.
Products Covered: Drugs ICS: 11.120.10. HS: 30
Regulation Type: Regular notification
Measures for Review and Approval of Drug Master File (DMF) in Support of Finished Drug Product Application (Draft)
Distribution date: 18 January 2018 | Final date for Comment: 19 March 2018
These measures are formulated to establish a drug quality management system in which marketing authorization holder is the first responsible person, to improve the quality and efficiency of drug registration, and to ensure the safety, effectiveness and quality of drug. Based on management process for review and approval of drug master file (DMF) in support of finished drug product application, these measures consist of seven parts, respectively，General Provisions, Responsibilities and Obligations, DMF Listing, Review and Approval of DMF in Support of Finished Drug Product Application, Alteration and Termination, Supervision and Management, Supplementary Articles.
Products Covered: Drugs ICS: 11.120.10 HS: 30
Regulation Type: Regular notification
Draft amendment of the Ministrial Notification No.875 of the Ministry of Agriculture, Forestry and Fisheries of 2014
Distribution date: 18 January 2018 | Final date for Comment: 17 February 2018
In order to use flesh-bone meal as an ingredient of fertilizers, taking measures to keep livestock away from them, such as adding designated materials, is required so that Transmissible Spongiform Encephalopathy (TSE) should be prevented. Now five materials proved to be effective in keeping livestock away are to be newly designated.
Products Covered: Fertilizer (HS: 3101, 3102, 3104, 3105)
Regulation Type: Regular notification
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