Regulatory Updates
The Resolution - RDC nº 293, 15 July 2019, changes article 19 of the RDC nº 205, 28 December 2017, notified through G/TBT/N/BRA/784 – that establishes special procedure for approval of clinical trials, good manufacturing practices certification and registration of new medicines for treatment, diagnosis or prevention of rare diseases. From: “The companies that submit a requirement of market authorization for new medicines according to the criteria of this resolution must submit the dossier for definition of maximum price concomitant with the protocol of the solicitation of market authorization” To: “The companies that submit a requirement of market authorization for new medicines according to the criteria of this resolution will have a deadline of 30 days to submit the dossier for definition of maximum price from the first business day after the publication of the market authorization of the medicine”. This resolution enters into force in the date its publication. The full text is available only in Portuguese and be downloaded at:
Distribution date: 19 July 2019
Products Covered: 3003 3004: Medicaments
Regulation Type: Addendum to Regular Notification
TITLE: Review of the Dust-Lead Hazard Standards and the Definition of Lead-Based Paint AGENCY: Environmental Protection Agency (EPA) ACTION: Final rule SUMMARY: Addressing childhood lead exposure is a priority for EPA. As part of EPA's efforts to reduce childhood lead exposure, EPA evaluated the current dust-lead hazard standards (DLHS) and the definition of lead-based paint (LBP). Based on this evaluation, this final rule revises the DLHS from 40 [micro]g/ft\2\ and 250 [micro]g/ft\2\ to 10 [micro]g/ft\2\ and 100 [micro]g/ft\2\ on floors and window sills, respectively. EPA is also finalizing its proposal to make no change to the definition of LBP because insufficient information exists to support such a change at this time. DATES: This final rule is effective 6 January 2020.
Distribution date: 17 July 2019
Products Covered: Lead-based paint
Regulation Type: Addendum to Regular Notification
National Standard of the P.R.C., Detergent Additive for Motor Gasoline
Distribution date: 16 July 2019 | Final date for Comment: 14 September 2019
This standard stipulates the terms and definitions, requirements and test methods, inspection rules, marking, packaging, transportation, storage and safety of detergent additive for motor gasoline. This standard applies to the detergent additive used in motor gasoline and motor ethanol gasoline.
Products Covered: Detergent Additive for Motor Gasoline
Regulation Type: Regular notification
Décret n° 2013 327 du 22 mai 2013 portant interdiction de la production, de l'importation, de la commercialisation, de la détention et de l'utilisation des sachets plastiques (Decree No. 2013-327 of 22 May 2013 prohibiting the production, importation, marketing, possession and use of plastic bags) (4 pages, in French)
Distribution date: 15 July 2019
The purpose of the decree is to prohibit the production, importation, marketing, possession and use of plastic bags.
Products Covered: Ordinary biodegradable and non-biodegradable plastic bags, composed of various hazardous chemical molecules including polyethylene, derived from petroleum, wax, calcium stearate, silanes, titanates, solvents, thermoplastics, thermosets, elastomers.
Regulation Type: Regular notification
Technical Regulation of Fire Fighting Systems and Devices
Distribution date: 12 July 2019 | Final date for Comment: 10 September 2019
This regulation specifies the following: Terms and Definitions, scope, objectives, supplier Obligations, Labeling, Conformity Assessment Procedures, Responsibilities of regulatory authorities, the authorities of market survey Responsibilities, Violations and Penalties, general rules, Transitional rules, Appendix (lists, types)
Products Covered: 3813; 4009; 7308; 7325; 8413; 8481; 8531.
Regulation Type: Regular notification
Draft Commission Regulation amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards lead and its compounds (6 pages + Annex 4 pages, in English)
Distribution date: 12 July 2019 | Final date for Comment: 10 September 2019
This draft Regulation would amend entry 63 to Annex XVII to Regulation (EC) No 1907/2006. It would prohibit the use of lead and lead compounds in articles produced from polymers or copolymers of vinyl chloride as well as their placing on the market in articles produced from PVC if the concentration of lead (expressed as metal) is equal to or greater than 0.1% by weight of the PVC material. Time-limited exemptions from this limit are provided for rigid and flexible recycled PVC material and for PVC-silica separators in lead acid batteries.
Products Covered: Articles made of polyvinyl chloride (PVC) containing lead and lead compounds.
Regulation Type: Regular notification
Notice of Modification to the List of Permitted Food Enzymes to Enable the Use of Lipase from Trichoderma reesei Morph Lip3 in Bread, Flour, Whole Wheat Flour, Unstandardized Bakery Products, and Pasta - Reference Number: NOM/ADM-0134
Distribution date: 09 July 2019 | Final date for Comment: 10 September 2019
Health Canada's Food Directorate completed a premarket safety assessment of a food additive submission seeking approval for the use of lipase from Trichoderma reesei Morph Lip3 in bread, flour, whole wheat flour, unstandardized bakery products, and pasta. Lipase from other source organisms is already permitted for use in Canada as a food enzyme in a number of foods including those of interest to the petitioner. The results of the premarket assessment support the safety and efficacy of lipase from T. reesei Morph Lip3 for its requested uses. Consequently, Health Canada has enabled the use of lipase from T. reesei Morph Lip3 described in the information document below by modifying the List of Permitted Food Enzymes (https://www.canada.ca/en/health-canada/services/food-nutrition/food-safety/food-additives/lists-permitted/5-enzymes.html), effective 27 June 2019. 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.
Products Covered: Lipase from Trichoderma reesei Morph Lip3 (ICS Code: 67.060)
Regulation Type: Regular notification
Partial revision of the Japanese Pharmacopoeia, Seventeenth edition (JP17-2, final rule) Revision to establish, amend and delete articles under Japanese Pharmacopoeia, Seventeenth edition notified in G/TBT/N/JPN/622 (dated 18 March 2019) was adopted and published on 28 June 2019. The outline of revision are available as attached file.
Distribution date: 08 July 2019
Products Covered: Pharmaceutical Products (HS:30)
Regulation Type: Addendum to Regular Notification
DUS DEAS 981:2019, Hydraulic road binders ― Composition, specifications and conformity criteria, First Edition.
Distribution date: 08 July 2019 | Final date for Comment: 06 September 2019
This Draft Uganda Standard applies to hydraulic road binders produced in a factory and supplied ready for use in road bases, sub-bases, capping layers, and soil stabilization or soil improvement. It specifies the mechanical, physical and chemical requirements for hydraulic road binders, together with the conformity criteria and evaluation procedures to be applied by the manufacturer. The stabilized road bases, sub-bases, capping layers, and soil stabilization or soil improvement by application of this hydraulic road binder shall comply with the requirements of BS 1924-1 Stabilized materials for civil engineering purposes ― Part 1: General requirements, sampling, sample preparation and tests on materials before stabilization and BS 1924 -2 Stabilized materials for civil engineering purposes ― Part 2: Methods of tests for cement-stabilized and lime–stabilized materials.
Products Covered: Hydraulic road binders
Regulation Type: Regular notification
Draft resolution (Consulta Publica) number 658, 24 June 2019, regarding maximum residue limit (MRL) of veterinary drugs in food of animal orign. Published on D.O.U., 26 June 2019
Distribution date: 03 July 2019 | Final date for Comment: 02 September 2019
This draft resolution establishes the procedure for risk assessment of veterinary drugs to human health and the methods for conformity assessment procedures.
Products Covered: HS Code(s): 30049085 (Veterinary medicinal preparations, not for human use, not elsewhere specified or included); ICS Code(s): 13, 65
Regulation Type: Regular notification
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