Distribution date: 08 January 2020 | Final date for Comment: 09 May 2025

The Food and Drug Administration (FDA or we) is responding to objections that it received from the Center for Food Safety on the final rule entitled "Listing of Color Additives Exempt from Certification; Soy Leghemoglobin", published on 1 August 2019. The final rule amended the color additive regulations to provide for the safe use of soy leghemoglobin as a color additive in ground beef analogue products. After reviewing the objections, FDA has concluded that the objections do not raise issues of material fact that justify a hearing or otherwise provide a basis for revoking the amendment to the regulations. We are also providing notice that the administrative stay of the effective date for this color additive regulation is now lifted.The final rule published in the Federal Register of 1 August 2019 (84 FR 37573) with an effective date of 4 September 2019, was administratively stayed by the filing of objections under section 701(e)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 371(e)(2)) as of 3 September 2019. FDA lifts the administrative stay as of 19 December 2019.

Products Covered: HS Code(s): 20, 3203; ICS Code(s): 67

Regulation Type: Addendum to Regular Notification

Distribution date: 09 January 2020 | Final date for Comment: 09 March 2020

The draft lifts certain veterinary measures applied to imported goods subject to veterinary control into the territory of the Eurasian Economic Union

Products Covered: Goods (products) subject to veterinary control and containing components of animal origin under the following HS codes of the Common Commodity Nomenclature of Foreign Economic Activity of the Customs Union. HS Code(s): 040900, 130190, 1502, 150300, 1504, 150500, 151800, 190220, 190420, 20, 2102, 2104, 2309, 2936, 30, 3002, 310100, 320300, 3302, 350400, 3507, 3808, 3824

Regulation Type: Regular notification

Distribution date: 09 January 2020 | Final date for Comment: 09 March 2020

This Draft Uganda standard specifies the requirements, sampling and test methods for Kikoi (also known as “Kikoy”).

Products Covered: Kikoi

Regulation Type: Regular notification

Distribution date: 09 January 2020 | Final date for Comment: 09 March 2020

This Draft Uganda standard specifies the requirements, sampling and test methods of Maasai Shuka.

Products Covered: Maasai Shuka

Regulation Type: Regular notification

Distribution date: 09 January 2020 | Final date for Comment: 07 April 2020

This Draft Resolution establishes the minimal technical requirements for relative bioavailability and bioequivalence studies that supports dossier of consent for clinical research, market authorization or post-market authorization of medicines, in the terms of this resolution.

Products Covered: HS Code(s): 3003; 3004; 3005; 2941 (pharmaceutical products).

Regulation Type: Regular notification

Distribution date: 09 January 2020 | Final date for Comment: 09 May 2025

Products Covered: 3303.00.00.00, 3304.10.00.00, 3304.20.00.00, 3304.30.00.00, 3304.91.00.00, 3305.10.00.00, 3305.20.00.00, 3305.30.00.00, 3305.90.00.00, 3306.10.00.00, 3306.90.00.00, 3307.10.00.00, 3307.20.00.00, 3307.30.00.00, and 3307.90.90.00. ;Perfumes and toilet waters (HS 330300); Lip make-up preparations (HS 330410); Eye make-up preparations (HS 330420); Manicure or pedicure preparations (HS 330430); Powders, whether or not compressed (HS 330491); Shampoos (HS 330510); Preparations for permanent waving or straightening (HS 330520); Hair lacquers (HS 330530); Other (HS 330590); Dentifrices (HS 330610); Other (HS 330690); Pre-shave, shaving or after-shave preparations (HS 330710); Personal deodorants and antiperspirants (HS 330720); Perfumed bath salts and other bath preparations (HS 330730); Other (HS 330790). ;

Regulation Type: Addendum to Regular Notification

Distribution date: 09 January 2020 | Final date for Comment: 25 March 2020

The draft guidelines for quality assessment and research of liposome-based drugs, micelles and drugs containing nanoparticle coatings apply to the development of copied drugs from the liposome, micelle and drug group, containing nanoparticle coatings for subsequent registration on the territory of the Eurasian economic Union and provides for the need to establish uniform requirements for the evidence-based study of the equal effectiveness and interchangeability of copied and reference drugs based on liposomes, micelles and drugs containing nanoparticle coatings used in the treatment and prevention of human diseases, in order to: identification of ineffective and (or) non-equivalent drugs at the pre-registration stage, resulting in the risk of harm to human life and health; elimination of the need to duplicate studies of these groups of drugs in each of the member States of the Union.  The draft guide has been prepared in order to: - protection of life and health of the patient (as the final consumer of medicines); - protection of the interests of the health care system as a whole (as the primary consumer of medicines) by ensuring the use of proven equally effective and interchangeable copied medicines; - protection of the interests of patients participating in the study by clearly regulating the procedure for conducting bioequivalence studies of these groups of drugs.

Products Covered: Medicaments consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses "incl. those in the form of transdermal administration" or in forms or packings for retail sale (excl. goods of heading 3002, 3005 or 3006) (HS code(s): 3004); Opacifying preparations for x-ray examinations; diagnostic reagents for administration to patients (HS code(s): 300630); Medicaments (ICS code(s): 11.120.10)

Regulation Type: Regular notification

Distribution date: 09 January 2020 | Final date for Comment: 09 March 2020

This Draft Uganda Standard specifies requirements, methods of sampling and test for three grades of gloss solvent-borne paints for interior and exterior use. This standard does not apply to automotive, road marking and Industrial applications.

Products Covered: Gloss solvent borne paints

Regulation Type: Regular notification

Distribution date: 09 January 2020 | Final date for Comment: 09 March 2020

Revision of the Mandatory Standard SI 4272, dealing with the safety, packaging and marking requirements for oven cleaners and grease removers. The major differences between the old edition and this new revised draft standard are as follow: Moves a few of the packaging requirements to Israel Mandatory Standard SI 2302 part 1; Adds to paragraph 2.2.7 an instruction for the maximum temperature of the surface intended to be cleaned; Changes the safety requirements according to the European Directive EC 1272/2008. All sections of the draft standard revision will be mandatory after its entry into force, except for the requirements relating to the warning label "Do not eat" appearing in paragraph 2.2.9.Both the old standard and the new revised standard will apply for a period of 3 years from the date of entry into force. During this time products may be tested for compliance according to the old or the new standard's edition.

Products Covered: Oven cleaners and grease removers

Regulation Type: Regular notification

Distribution date: 10 January 2020 | Final date for Comment: 09 May 2025

This joint normative instruction establishes the guidelines for the market authorization of pesticides and related products designed to the cultivation of ornamental plants as well as for the inclusion of products already authorized.

Products Covered: HS Code(s): 06, 0603, 0604, 38089910; ICS Code(s): 13, 65

Regulation Type: Regular notification