Regulatory Updates
Proyecto de Reglamento que establece las reglas de clasificación y los principios esenciales de seguridad y desempeño de los dispositivos médicos (Draft Regulation establishing the classification rules for and the essential principles of safety and performance of medical devices) (34 pages, in Spanish)
Distribution date: 08 May 2017 | Final date for Comment: 02 August 2017
The aims of the notified draft Regulation are as follows: · to establish the rules governing the classification of medical devices by risk level, pursuant to Article 6.2 of Law No. 29459 (Law on pharmaceutical products, medical devices and sanitary products), for sanitary registration purposes; · to establish the essential principles of safety and performance to be respected by the manufacturers of medical devices in order to demonstrate that such products are safe and perform in accordance with the manufacturer's intended end use.
Products Covered: Medical devices classified under Chapter 30 of the Harmonized System or Customs Tariff
Regulation Type: Regular notification
Proyecto de Reglamento que regula la expedición del certificado de liberación de lote de productos biológicos: vacunas o derivados de plasma humano (Draft Regulation on the issue of batch release certificates for biological products (vaccines or human plasma derivatives)) (6 pages, in Spanish).
Distribution date: 08 May 2017 | Final date for Comment: 02 August 2017
The aims of the notified draft Regulation are to: · establish the rules governing the issue of batch release certificates for biological products (vaccines or human plasma derivatives) issued by the National Authority for Pharmaceutical Products, Medical Devices and Sanitary Products; · establish the information to be included in the documents required for the issue of batch release certificates for biological products (vaccines or human plasma derivatives).
Products Covered: Pharmaceutical products classified under Chapter 30 of the Harmonized System or Customs Tariff
Regulation Type: Regular notification
Amendment to the Enforcement Order of Industrial Safety and Health Act and related ordinances about the 10 substances
Distribution date: 08 May 2017 | Final date for Comment: 15 June 2017
The Enforcement Order of Industrial Safety and Health Act and related ordinances are to be partially amended to place obligations on the business operators relating to the 10 substances.
Products Covered: Asphalt (HS 2706), 1-Chloro-2-propanol (HS 2922), 2-Chloro-1-propanol (HS 2922), S-tert-butylthiomethyl O,Odiethylphosphorodithioate (HS 2930), Phenyl isocyanate (HS 2929), 2,3-Butanedione (HS2914), Boric acid (HS 2810), Portlamd cement (HS 2523), 2-methoxy-2-methylbutane (HS2909), Carbonyl sulphide (HS 2830) and preparations containing them (hereinafter referred to as the "10 substances")
Regulation Type: Regular notification
Indirect Food Additives: Polymers; Final Rule
Distribution date: 05 May 2017
The Food and Drug Administration (FDA) is amending the food additive regulations to no longer provide for the use of potassium perchlorate as an additive in closuresealing gaskets for food containers because this use has been abandoned. This action is in response to a petition filed by Keller and Heckman LLP on behalf of the Society of the Plastics Industry, Inc.The rule is effective 4 May 2017.The text is available at http://members.wto.org/crnattachments/2017/SPS/USA/17_2174_00_e.pdf
Products Covered:
Regulation Type: Addendum to Regular Notification
TITLE: Trichloroethylene; Regulation of Vapor Degreasing Under TSCA Section 6(a); Methylene Chloride and N-Methylpyrrolidone; Regulation of Certain Uses Under TSCA Section 6(a); Reopening of Comment Periods AGENCY: Environmental Protection Agency (EPA) ACTION: Notice; Reopening of comment periods SUMMARY: In the Federal Register of 19 January 2017, EPA issued two proposed rules under section 6 of the Toxic Substances Control Act (TSCA). The first action proposed to prohibit the manufacture (including import), processing, and distribution in commerce of trichloroethylene (TCE) for use in vapor degreasing; to prohibit the use of TCE in vapor degreasing; to require manufacturers (including importers), processors, and distributors, except for retailers, of TCE for any use to provide downstream notification of these prohibitions throughout the supply chain; and to require limited recordkeeping. The second action proposed to prohibit the manufacture (including import), processing, and distribution in commerce of methylene chloride and N- methylpyrrolidone (NMP) for consumer and most types of commercial paint and coating removal; to prohibit the use of methylene chloride and NMP in these commercial uses; to require manufacturers (including importers), processors, and distributors, except for retailers, of methylene chloride and NMP for any use to provide downstream notification of these prohibitions throughout the supply chain; and to require recordkeeping. This document reopens and extends the comment periods for each proposed rule for an additional 30 days. Commenters requested additional time to submit written comments for the proposed rules. Comments, identified by docket identification (ID) number EPA- HQ-OPPT-2016-0387 and by docket identification (ID) number EPA-HQ-OPPT- 2016-0231 must be received on or before 19 May 2017.
Distribution date: 04 May 2017
Products Covered: Methylene chloride and N-Methylpyrrolidone
Regulation Type: Addendum to Regular Notification
Commission Implementing Regulation (EU) 2017/731 of 25 April 2017 amending model veterinary certificates BOV-X, BOV-Y, BOV and OVI set out in Annexes I and II to Regulation (EU) No 206/2010, the model certificates GEL, COL, RCG and TCG set out in Annex II to Implementing Regulation (EU) 2016/759 and the model certificate for composite products set out in Annex I to Regulation (EU) No 28/2012 in relation to the rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies (Text with EEA relevance)
Distribution date: 03 May 2017
Amendments of the model certificates for imports of live domestic bovine animals, fresh meat and minced meat of bovine, ovine and caprine origin, gelatine, collagen, raw material for production of gelatine and collagen, treated raw material for production of gelatine and collagen and of composite products with products of bovine, ovine and caprine origin, as regards the public health attestation for BSE: - Clarification of the text concerning import of live domestic bovine animals and products of animal origin from bovine, ovine or caprine animals. - Amendment of the requirement for import of carcasses of bovine origin, as the requirement to indicate a blue stripe on the label when removal of the vertebral column is not required, is changed to indicate a red stripe on the label when such removal is required. - Modification of the import requirements for the products coming from countries with a negligible BSE risk, to allow also for import when such products originate from raw material from countries with controlled or undetermined BSE risk, provided that SRM has been removed.
Products Covered: Domestic bovine animals, fresh meat (including minced meat) of domestic bovine, ovine and caprine animals, gelatine, collagen, raw material for production of gelatine and collagen, treated raw material for production of gelatine and collagen, composite products.
Regulation Type: Regular notification
TITLE: Trichloroethylene; Regulation of Vapor Degreasing Under TSCA Section 6(a); Methylene Chloride and N-Methylpyrrolidone; Regulation of Certain Uses Under TSCA Section 6(a); Reopening of Comment Periods AGENCY: Environmental Protection Agency (EPA) ACTION: Notice; Reopening of comment periods SUMMARY: In the Federal Register of 19 January 2017, EPA issued two proposed rules under section 6 of the Toxic Substances Control Act (TSCA). The first action proposed to prohibit the manufacture (including import), processing, and distribution in commerce of trichloroethylene (TCE) for use in vapor degreasing; to prohibit the use of TCE in vapor degreasing; to require manufacturers (including importers), processors, and distributors, except for retailers, of TCE for any use to provide downstream notification of these prohibitions throughout the supply chain; and to require limited recordkeeping. The second action proposed to prohibit the manufacture (including import), processing, and distribution in commerce of methylene chloride and N- methylpyrrolidone (NMP) for consumer and most types of commercial paint and coating removal; to prohibit the use of methylene chloride and NMP in these commercial uses; to require manufacturers (including importers), processors, and distributors, except for retailers, of methylene chloride and NMP for any use to provide downstream notification of these prohibitions throughout the supply chain; and to require recordkeeping. This document reopens and extends the comment periods for each proposed rule for an additional 30 days. Commenters requested additional time to submit written comments for the proposed rules. Comments, identified by docket identification (ID) number EPA- HQ-OPPT-2016-0387 and by docket identification (ID) number EPA-HQ-OPPT- 2016-0231 must be received on or before 19 May 2017.
Distribution date: 03 May 2017
Products Covered: Trichloroethylene (TCE)
Regulation Type: Addendum to Regular Notification
Notification of the adopted Animal Health Requirements for raw milk/milk products to be exported to Japan
Distribution date: 01 May 2017
As was announced in G/SPS/N/JPN/471/Add.1 dated 14 November 2016, the revised Article 45 of "the Ministerial Ordinance for Enforcement of the Act on Domestic Animal Infectious Disease Control" will enter into force on 1 November 2017, and raw milk/milk products will be added to the list of items subject to animal health quarantine. In G/SPS/N/JPN/471/Add.2 dated 16 February 2017, MAFF proposed the draft Animal Health Requirements to set out detailed import conditions including required statements in the health certificate to be applied to raw milk/milk products to be imported into Japan from 1 November 2017(*). This is to notify of the adopted Animal Health Requirements: http://members.wto.org/crnattachments/2017/SPS/JPN/17_2055_00_e.pdf The model format of the health certificate for the countries listed on the Annex of the Animal Health Requirements: http://members.wto.org/crnattachments/2017/SPS/JPN/17_2055_01_e.pdf The model format of the health certificate for non-listed countries: http://members.wto.org/crnattachments/2017/SPS/JPN/17_2055_02_e.pdf (*)Note: Raw milk/milk products arriving in Japan on and after 1 November 2017, including products exported from exporting countries before 1 November 2017, will need to be accompanied by the health certificate issued by the competent authority of the exporting country in accordance with the AHRs.
Products Covered:
Regulation Type: Addendum to Regular Notification
DUS 1755:2017, Standard Test Method for Water in Organic Liquids by Coulometric Karl Fischer Titration.
Distribution date: 01 May 2017 | Final date for Comment: 30 June 2017
This draft test method covers the determination of water from 0 to 2.0% mass in most liquid organic chemicals, with Karl Fischer reagent, using an automated coulometric titration procedure. Use of this test method is not applicable for liquefied gas products such as Liquid Petroleum Gas (LPG), Butane, Propane, Liquid Natural Gas (LNG), etc.
Products Covered: Organic Liquids.
Regulation Type: Regular notification
DUS 1754:2017, Standard Practice for Sampling Industrial Chemicals.
Distribution date: 01 May 2017 | Final date for Comment: 30 June 2017
This draft test method covers procedures for sampling several classes of industrial chemicals. It also includes recommendations for determining the number and location of such samples, to ensure their being representative of the lot in accordance with accepted probability sampling principles.
Products Covered: Industrial Chemicals.
Regulation Type: Regular notification
Submit your email ID to receive notifications about upcoming courses and events
