Chemical Regulatory Updates – Latest Global Changes

Packing for Fireworks (9 pages, in Chinese) ;

Distribution date: 24 March 2015 | Final date for Comment: 23 May 2015

This standard applies to the packing of fireworks products other than black powder, pyrotechnic composition as well as the ignition fuse.

Products Covered: Fireworks and firecrackers (HS Code: 36041000)

Regulation Type: Regular notification

<pre>TITLE: Current Good Manufacturing Practice Requirements for Combination Products; Draft Guidance for Industry and Food and Drug Administration Staff; AvailabilityAGENCY: Food and Drug Administration, HHSACTION: NoticeSUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry and FDA staff entitled "Current Good Manufacturing Practice Requirements for Combination Products." The guidance describes and explains the final rule on current good manufacturing practice (CGMP) requirements for combination products, including presenting general considerations for CGMP compliance as well as analysis of hypothetical scenarios.DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by 30 March 2015.URLs:</pre>http://www.gpo.gov/fdsys/pkg/FR-2015-01-27/html/2015-01410.htm http://www.gpo.gov/fdsys/pkg/FR-2015-01-27/pdf/2015-01410.pdf

Distribution date: 17 March 2015

Products Covered: Combination products (HS: 3004, 9018.11-90) (ICS: 71.100, 13.020)

Regulation Type: Addendum to Regular Notification

<pre>TITLE: Current Good Manufacturing Practice Requirements for Combination Products; Draft Guidance for Industry and Food and Drug Administration Staff; Extension of Comment PeriodAGENCY: Food and Drug Administration, HHSACTION: Notice; extension of comment periodSUMMARY: The Food and Drug Administration (FDA) is extending the comment period by 30 days to 29 April 2015, for the notice entitled "Current Good Manufacturing Practice Requirements for Combination Products; Draft Guidance for Industry and Food and Drug Administration Staff; Availability," that appeared in the Federal Register of 27 January 2015 (80 FR 4280). In that document, FDA announced the availability of a draft guidance for industry and FDA staff and requested comments. The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.DATES: FDA is extending the comment period on the draft guidance. Submit either electronic or written comments by 29 April 2015.URLs:</pre>http://www.gpo.gov/fdsys/pkg/FR-2015-03-13/html/2015-05674.htm http://www.gpo.gov/fdsys/pkg/FR-2015-03-13/pdf/2015-05674.pdf

Distribution date: 17 March 2015

Products Covered: Combination products (HS: 3004, 9018.11-90) (ICS: 71.100, 13.020)

Regulation Type: Addendum to Regular Notification

New Regulation 27B, Food Regulations 1985: Plastic Materials and Articles

Distribution date: 17 March 2015 | Final date for Comment: 16 May 2015

The regulation provides the maximum proportion of release of chemical substances and specific migration limit or total specific migration limit to ensure that plastic materials and articles that are intended to come into contact with food, already in contact with food or which can reasonably be expected to come into contact with food meet with the minimum safety requirements.

Products Covered: All food

Regulation Type: Regular notification

Human health Food safety Contaminants

Proposed amendments to the regulation of Food and Drugs Testing Laboratories Assessment

Distribution date: 12 March 2015 | Final date for Comment: 14 April 2015

a. Amend Annex 4. LAQAS (Laboratory Quality Assurance Standards) of the regulation of Food and Drugs Testing Laboratories Assessment to install testing record management system (such as Audit trail for instruments, using laboratory notebook for manual testing, etc). b. Amend the Certificate of Laboratory Testing to minimize fraud possibility. c. Establish requirements of re-operating laboratory after service suspension due to testing ability.

Products Covered: Testing laboratories (food, livestock product, drug, traditional Korean medicinal substance, medical device, cosmetics)

Regulation Type: Regular notification

Human health Food safety Certification, control and inspection

Draft Notification of the Committee on Labels No. (B.E. ): Lead-Containing Paints Required Labelling Control (1 page, in Thai)

Distribution date: 11 March 2015 | Final date for Comment: 10 May 2015

The Office of the Consumer Protection Board (OCPB) has proposed draft Notification of the Committee on Labels No. (B.E. ): Lead-Containing Paints Required Labelling Control, including definition of paints, label contents and font sizes as follows:<ul><li>"Paints" mean paint used for exterior or interior of a house or a building</li><li>Lead-containing paints required labelling control must  comply with Clause 1 to Clause 3 of the Notification of the Committee on Labels: Characteristics of Labels Subject to the Labelling Control B.E.2541(1998) dated 23 September B.E. 2541(1998), and the label must contain the following information:</li></ul><ol start="1" style="margin-left:30px;"><li>The quantity of lead in paints in part per million (ppm)</li><li>If the quantity of lead is more than 100 ppm, following warning shall be displayed "Lead may harm human brain and erythrocyte, prohibited from painting house or building"</li></ol><ul><li>The font must use bold red colour, the size shall not be less than 5 mm with white background and at noticeable position.</li></ul>

Products Covered: Lead-containing paints (HS: 3208, 3209; ICS: 87.040)

Regulation Type: Regular notification

Notification of the Ministry of Industry No. (B.E. 25xx) Issued under the Industrial Product Standards Act B.E. 2511(1968): Amending to Thai Industrial Standard for Steel Bars for Reinforced Concrete: Deformed Bars (Amendment No. 1) (3 pages, in Thai)

Distribution date: 09 March 2015 | Final date for Comment: 08 May 2015

The Thai Industrial Standards Institute (TISI) has proposed to amend the Thai Industrial Standard for Steel Bars for Reinforced Concrete: Deformed Bars (TIS 24-2548(2005)).  The main amendment includes chemical composition (ladle analysis) and tolerances and marking.

Products Covered: Steel bars (HS:7214, ICS: 77.140.60)

Regulation Type: Regular notification

Notification of the Ministry of Industry No. (B.E. 25xx) Issued under the Industrial Product Standards Act B.E. 2511(1968): Amending to Thai Industrial Standard for Steel Bars for Reinforced Concrete: Round Bar (Amendment No. 1) (3 pages, in Thai)

Distribution date: 09 March 2015 | Final date for Comment: 08 May 2015

The Thai Industrial Standards Institute (TISI) has proposed to amend the Thai Industrial Standard for Steel Bars for Reinforced Concrete: Round Bar (TIS 20-2543(2000)). The main amendment includes chemical composition (ladle analysis) and tolerances, marking and sampling plan.

Products Covered: Steel bars (HS:7214, ICS: 77.140.60)

Regulation Type: Regular notification

PROY-NOM-073-SSA1-2014, Estabilidad de fármacos y medicamentos, así como de remedios herbolarios (21 páginas, en español)

Distribution date: 27 February 2015

La norma notificada es de observancia obligatoria para: las fábricas o laboratorios de materias primas para la elaboración de medicamentos o productos biológicos, para uso humano y fábricas o laboratorios de medicamentos o productos biológicos para uso humano o fábricas o laboratorios de remedios herbolarios, que producen fármacos, medicamentos, así como remedios herbolarios, que se comercialicen en los Estados Unidos Mexicanos.

Products Covered: Human blood; animal blood prepared for therapeutic, prophylactic or diagnostic uses; antisera and other blood fractions and modified immunological products, whether or not obtained by means of biotechnological processes; vaccines, toxins, cultures of micro-organisms (excl. yeasts) and similar products (HS code(s): 3002); Medicaments consisting of two or more constituents mixed together for therapeutic or prophylactic uses, not in measured doses or put up for retail sale (excl. goods of heading 3002, 3005 or 3006) (HS code(s): 3003); Essential oils, whether or not terpeneless, incl. concretes and absolutes; resinoids; extracted oleoresins; concentrates of essential oils in fats, fixed oils, waxes or the like, obtained by enfleurage or maceration; terpenic by-products of the deterpenation of essential oils; aqueous distillates and aqueous solutions of essential oils (HS code(s): 3301)

Regulation Type: Regular notification

Human health

Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Act (revision of agricultural chemical residue standards)

Distribution date: 27 February 2015 | Final date for Comment: 28 April 2015

Proposed maximum residue limits (MRLs) for the following agricultural chemical: Pesticide - Malathion

Products Covered: - Meat and edible meat offal (HS Codes: 02.01, 02.02, 02.03, 02.04, 02.05, 02.06, 02.07, 02.08 and 02.09) - Fish and crustaceans, molluscs and other aquatic invertebrates (HS Codes: 03.02, 03.03, 03.04 and 03.07) - Dairy produce, birds' eggs and natural honey (HS Codes: 04.01, 04.07 and 04.08) - Products of animal origin (HS Code: 05.04) - Edible vegetables and certain roots and tubers (HS Codes: 07.01, 07.02, 07.03, 07.04, 07.05, 07.06, 07.07, 07.08, 07.09, 07.10, 07.13 and 07.14) - Edible fruits and nuts, peel of citrus/melons (HS Codes: 08.01, 08.02, 08.03, 08.04, 08.05, 08.06, 08.07, 08.08, 08.09, 08.10, 08.11 and 08.14) - Coffee, tea, mate and spices (HS Codes: 09.01, 09.02, 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10) - Cereals (HS Codes: 10.01, 10.02, 10.03, 10.04, 10.05, 10.06, 10.07 and 10.08) - Oleaginous fruits, miscellaneous grains, seeds and fruits (HS Codes: 12.01, 12.02, 12.04, 12.05, 12.06, 12.07, 12.10 and 12.12) - Animal or vegetable fats and oils (HS Codes: 15.01, 15.02 and 15.06) - Cacao and cacao preparations (HS Code: 18.01)

Regulation Type: Regular notification

Human health Pesticides Maximum residue limits (MRLs) Food safety

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Regulatory Updates

Packing for Fireworks (9 pages, in Chinese) ;

New Regulation 27B, Food Regulations 1985: Plastic Materials and Articles

Proposed amendments to the regulation of Food and Drugs Testing Laboratories Assessment

Draft Notification of the Committee on Labels No. (B.E. ): Lead-Containing Paints Required Labelling Control (1 page, in Thai)

Notification of the Ministry of Industry No. (B.E. 25xx) Issued under the Industrial Product Standards Act B.E. 2511(1968): Amending to Thai Industrial Standard for Steel Bars for Reinforced Concrete: Deformed Bars (Amendment No. 1) (3 pages, in Thai)

Notification of the Ministry of Industry No. (B.E. 25xx) Issued under the Industrial Product Standards Act B.E. 2511(1968): Amending to Thai Industrial Standard for Steel Bars for Reinforced Concrete: Round Bar (Amendment No. 1) (3 pages, in Thai)

PROY-NOM-073-SSA1-2014, Estabilidad de fármacos y medicamentos, así como de remedios herbolarios (21 páginas, en español)

Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Act (revision of agricultural chemical residue standards)