FD&C Red 40 Lake

FD&C Red 40 Lake

FD&C Red 40 Lake

Neelilake Allura Red Lake/ Neelicert FD & C Red 40 Lake Allowed in the list of approved colours under Rule 127 of the Drugs and  Cosmetics Rules, 1945

The FD & C Red 40 / Allura Red & their Aluminium Lakes are worldwide used in Food, Drugs & Cosmetic products by following various countrywise legislations.

  1. CFR – Code of Federal Regulations Title 21, Part- 74.
  2. Indian Cosmetic standard IS 4707.
  3. European Food Directive (EU) No 231/2012 of 9 March 2012 for use in Food product & EC Cosmetic Directive (EC) No 1223/2009 of the council of 30 November 2009.
  4. Joint FAO/WHO Expert Committee on Food Additives (JECFA),  82nd  Meeting 2016.
  5. Chinese Standards for Food Additive & Cosmetic Products.

As per the Minutes of the 85th Meeting (Virtual) of Drugs Technical Advisory Board held on 29.07.2020 at DGHS, Nirman Bhawan, New Delhi, DTAB recommended to amend the Rule 127 of the Drugs and Cosmetics Rules, 1945 to include FD&C Red # 40 Aluminum Lake (E l29) Allura red colour.

For MOM detail please refer below link:

https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadCommitteeFiles/Minutes%20for%2085th%20DTAB%20meeting%20held%20on%2029-07-2020.pdf

Neelikon Food Dyes & Chemicals Ltd., has emerged as a prime manufacturer of high quality Dyes and Lakes for Food, Pharmaceutical & Cosmetics including Allura Red/ FD & C Red 40 and their Aluminium Lakes since last 35 years. The majority of this production is exported around the world. We are pioneer in manufacturing of USFDA Certified material in Food, Pharma and Cosmetic market globally. Neelikon is regarded as one of the top three producers in the world for Food, Drugs & Cosmetic Dyes.

Based on above Minutes of the 85th Meeting (Virtual) of Drugs Technical Advisory Board (DTAB) held on 29.07.2020, FD&C Red # 40 Aluminum Lake (E129) Allura Red Colour  listed as approved colours under rule 127 of the Drugs and Cosmetics Rules, 1945. Also Food Safety and Standards Authority of India (FSSAI) has also approved FD&C Red # 40 Aluminum Lake (E l29) (Allura red) as colorant in food products in India

To be more specific, customer need to understand the difference between Allura Red Aluminium Lake and FD&C Red 40 Aluminium Lake before placing their order. Allura Red Aluminium Lake is a non- certify grade of FD&C Red 40 Aluminium Lake which doesn’t require batch certification from USFDA whereas, FD&C Red 40 Aluminium Lake requires batch certification from USFDA. Thus, for use of this colour in Indian market, producer doesn’t need to use certify version of the same.

As a pioneer manufacturer we are grateful to inform  that we are manufacturing huge quantity of FD & C Red # 40 Aluminum Lake and Allura Red Aluminium Lake and catering globally meeting all legislative requirement as stated above ( a to e ) including India for Food, Drug and Cosmetic application. These lakes are available as Low, Medium and High Strength.

We are grateful to our customer for enquiry to provide above products which Neelikon can provide as  “Neelilake Allura Red Lake and  Neelicert FD & C Red 40 Lake” to our Indian Customers as well.

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