<![CDATA[REGULATORY AFFAIRS ASIA - Regulatory Updates]]>Sun, 22 Mar 2020 12:48:48 +0800Weebly<![CDATA[New stat board Singapore Food Agency to be formed in April 2019]]>Tue, 31 Jul 2018 16:11:57 GMThttp://regulatoryaffairsasia.com/regulatory-updates/new-stat-board-singapore-food-agency-to-be-formed-in-april-2019Singapore Food Agency will be established in April 2019. The new stat board will consolidate all the food related functions from Health Sciences Authority (HSA), National Environment Agency (NEA) and Agri-Food & Veterinary Authority (AVA). AVA which is currently responsible for regulating food products in Singapore will cease operation. It is expected that new statutory board would better support the local food sector and help boost its efficiency.

<![CDATA[Updates on asean harmonisation of tmhs]]>Fri, 11 May 2018 02:10:26 GMThttp://regulatoryaffairsasia.com/regulatory-updates/updates-on-asean-harmonisation-of-tmhsThe ACCSQ TMHS PWG has its 29th meeting last month at Siem Reap, Cambodia. Though we had hoped that the PWG could finalise the Agreements and proceed with signing by early next year, issues on the industries' readiness/capability to implement the agreed technical requirements, in particular Stability Study and Shelf Life requirements, and GMP requirements were raised, as a result, the PWG was not able to proceed further until the matters are resolved.  The PWG will meet again in October 18 for further discussion. The tentative date for signing of the Agreement has now pushed back to October 2019, however we are still uncertain if the issues can be resolved by the next meeting.

The 2 Industry associations present at the product working group acknowledged that companies, especially the SME have difficulties meeting the stringent technical requirements, they are committed to upgrade the industry standards, as long as they are sufficient support in capacity building programmes.
<![CDATA[new provisions for the use of food additives and ingredients in singapore]]>Thu, 29 Mar 2018 06:22:37 GMThttp://regulatoryaffairsasia.com/regulatory-updates/new-provisions-for-the-use-of-food-additives-and-ingredients-in-singaporeThe Singapore Agri-Food & Veterinary Authority has issued an amendment  to the Food Regulation. The following are the key changes
  1. New permitted food additives (emulsifiers)Partially hydrolysed lecithin and amidated pectin as permitted emulsifiers in food under good manufacturing practice
  2. New permitted nutrient supplement source (folate): Calcium L-methylfolate
  3. New permitted nutrient supplement source (Vitamin K)phylloquinone and menanquinone-7 as sources of Vitamin K1 and Vitamin K2, respectively
  4. New permitted ingredients for infant formula2'-fucosyllactose (2'-FL) and Lacto-N-neotetraose (LNnT), for use in infant formula at levels up to 120mg and 60mg respectively per 100ml
  5. Expanded scope of use for existing food additive (Benzoic acid and sorbic acid): Benzoic acid (and its sodium and potassium salts) and sorbic acid (and its sodium, potassium and calcium salts) for use in the food category "Semi- preserved caviar and other fish roe products" at levels up to 2000 ppm and 1000 ppm, calculated as benzoic acid and sorbic acid respectively
  6. Expanded scope of use for existing food additive (Sucralose): Permitted in the food category “Cheese-based preparations” at levels up to 500 ppm 
  7. Expanded scope of use for existing food additive (phosphoric acids) Sodium, calcium and potassium salts of phosphoric acid as permitted emulsifiers and/or stabilisers 
  8. Removal of food additives from the permitted list: propyl para- hydroxybenzoate (INS 216) and sodium propyl para-hydroxybenzoate (INS 217) are deleted from the permitted list

The changes are in line with the international standards, such as Codex General Standards for Food Additives.
As Singapore relies heavily on imported products, the food authority will ensure the regulations align with international practice and does not impede trade.

<![CDATA[29th ACCSQ TMHS PWG meeting]]>Mon, 19 Mar 2018 03:53:18 GMThttp://regulatoryaffairsasia.com/regulatory-updates/29th-accsq-tmhs-pwg-meetingThe 29th ACCSQ Traditional Medicines and health Supplements Product Working Group is expected to be held from 16 - 20 April 2018 at Siem Reap Cambodia. The Meeting hope to reach consensus on the ASEAN agreement on Traditional Medicines and Health Supplement. As of to date, the date for signing of the agreement has been pushed back to April 2019.
The Product Working Group’s scientific committee ATSC will be discussing on the Q&A for the Guiding Principles on Safety substantiation and Guiding Principles for Stability and Shelf life studies. The questions listed on the Q&A were consolidated from the feedback of the ASEAN governments and industry participants, who attended the trainings held in 2017. The ATSC will also be discussing on the training program for claims and claims substantiation. The training on Claims and claims substantiation is expected to be held on the 2nd half of 2018.