PUBLIC CONSULTATION ON THE DELETION OF PROVISIONS FOR PROPYL PARA-HYDROXYBENZOATE AND ITS SODIUM SALT FROM THE FOOD REGULATIONS
Agri-Food and Veterinary Authority (Regulatory Programmes Department)
- Consultation Period:
- 20 Apr 2016 - 20 Jun 2016
- Status:
- Closed - Summary of Responses
Consultation Outcome
RESPONSE TO COMMENTS RECEIVED FROM THE PUBLIC CONSULTATION ON DELETION OF PROVISIONS FOR PROPYL PARA-HYDROXYBENZOATE AND ITS SODIUM SALT FROM THE FOOD REGULATIONS
The Agri-Food and Veterinary Authority of Singapore (AVA) initiated a public consultation exercise for the period 20 April 2016 to 20 June 2016 on the deletion of provisions for propyl para-hydroxybenzoate and its sodium salt from the Food Regulations. Feedback was sought from the food industry (local manufacturers and importers) on the following:
- Whether propyl para-hydroxybenzoate (INS 216) and sodium propyl parahydroxybenzoate (INS 217) are used in food products imported/manufactured and sold by the company; and
- In the event that INS 216 or INS 217 is used in food products imported/manufactured by the company,
- For importers: the estimated length of time that the company will need in order to source for similar food products that do not contain INS 216 or INS 217
- For local manufacturers: the estimated length of time that the company will need to reformulate its products to exclude the use of these preservatives
A total of 22 responses to the public consultation exercise were received. 19 industry members informed AVA that INS 216 and 217 were not used in the food products which they import and/or manufacture for sale in Singapore, and that they have no objection to the proposed deletion. Two business associations indicated support for the proposed amendment, of which one suggested that sufficient time be provided to establishments to comply with the proposed amendments. One industry member was not in favour of the proposed deletion, noting that a few countries still continue to allow the use of INS 216 and 217, and a ban on the use of these two preservatives may limit the available sources for food import.
AVA has responded to all the feedback and comments provided by the industry members. With regard to the concern raised by the industry member, we have data collected from previous years through routine surveillance which showed that INS 216 and 217 are rarely used in food products sold in Singapore. Although some countries (such as Taiwan, Korea and Japan) have not officially banned the use of these two preservatives, it is likely that their industry has stopped the usage due to safety concerns. There are other preservatives which perform the same technological functions as INS 216 and 217; namely methyl parahydroxybenzoate (INS 218) and sodium methyl parahydroxybenzoate (INS 219), and the industry can make the necessary changes to their product formulation.
Based on the feedback received, AVA notes that the industry is ready for the implementation of the proposed changes now. As such, AVA plans to incorporate the proposed deletion of the preservatives in the 2017 amendments to the Food Regulations. After official gazettal of the amendments, the industry will be given a 12-month grace period to exhaust existing supplies of food products which may still contain INS 216 or INS 217. Therefore, AVA would encourage the industry to make use of the time from now till the final implementation (which is at least two years) to make the necessary changes to their businesses to ensure a smooth implementation.
AVA appreciates the time taken by individuals and organisations to submit feedback and comments which have contributed to the decision making process, and would like to
encourage all food industry members to actively participate in future calls for comments.Summary
Detailed Description
Background
Propyl para-hydroxybenzoate (INS 216) and sodium propyl para-hydroxybenzoate (INS 217) are permitted Class II chemical preservatives under Regulation 19(2)(b) of the Food Regulations. They may be added to the following food categories specified under the Fourth Schedule up to the corresponding maximum levels:
| Food Category | Maximum level
(ppm of propyl para-hydroxybenzoate)
|
| Beer | 70 |
| Coffee (or coffee mixture or liquid extract) | 450 |
| Colouring matter, if in the form of a solution of a permitted colouring matter | 2000 |
| Drinking chocolate concentrate | 700 |
| Fillings and toppings (fruit or vegetable based) | 800 |
| Flavouring emulsions or flavouring syrup | 800 |
| Fruits, crystallised, glace or drained | 1000 |
| Fruit (other than fresh fruit or fruit pulp not otherwise specified in this Table) | 800 |
| Fruit drink or fruit crush | 400 |
| Fruit juices | 400 |
| Fruit juices, concentrate | 800 |
| Glucose drink containing solid contents not less than 23.5% (w/v) of glucose | 400 |
| Jam, including preserves sold for dietetic purposes | 500 |
| Pickles other than pickled vegetables that require washing before consumption | 250 |
| Pickled vegetables that require washing before consumption | 1000 |
| Salad dressing | 250 |
| Sauces | 250 |
| Silicon anti-foam emulsion | 2000 |
| Soft drinks for consumption before dilution | 800 |
| Soft drinks for consumption without dilution (other than fruit drink or fruit crush) | 160 |
| Tomato pulp, paste or puree | 800 |
| Yoghurt, fruits | 120 |
Following a review on the safety of propyl para-hydroxybenzoates by the European Food Safety Authority (EFSA), both INS 216 and INS 217 were no longer permitted for use in the European Union. This was due to their negative effects on sex hormones and the male reproductive organs of juvenile rats.
The Joint FAO/WHO Expert Committee on Food Additives (JECFA) similarly identified significant toxicological concerns with INS 216, and concluded that the safety of INS 216 could not be established. Arising from JECFA’s assessment, the Codex Alimentarius Commission1 (CAC) had discontinued work on draft provisions for the use of INS 216 in the Codex General Standard for Food Additives, and also revoked provisions for the use of INS 216 in relevant Codex commodity standards. JECFA has never evaluated the safety of INS 217 and Codex has not adopted any provisions for the use of INS 217.
Internationally, INS 216 and INS 217 are not permitted for use in food in a number of countries, such as Australia, New Zealand, the European Union, Hong Kong, Malaysia and Indonesia.
Proposed amendment
AVA has conducted a review on the use of INS 216 and INS 217. In view of the potential for adverse effects on human health and the availability of alternative preservatives, these two preservatives will no longer be allowed for use in food. Consequently, all existing provisions for the use of INS 216 and INS 217 will be removed from the Food Regulations.
Industry members can continue to use other Class II chemical preservatives permitted under the Food Regulations.
Request for comments
AVA invites views and comments from the food industry on:
- Whether propyl para-hydroxybenzoate (INS 216) and sodium propyl para-hydroxybenzoate (INS 217) are used in food products imported/ manufactured and sold by your company; and
- In the event that INS 216 or INS 217 is used in food products imported/manufactured by your company,
- For importers: the estimated length of time that your company will need in order to source for similar food products that do not contain INS 216 or INS 217.
- For local manufacturers: the estimated length of time that your company will need to reformulate your products to exclude the use of these preservatives.
All submissions should be clearly and concisely written, and should provide a reasoned explanation for any proposed revisions.
Submissions should reach AVA no later than 12:00 p.m., 20 June 2016, through mail or email, to the following addresses:
Mail:
Regulatory Programmes Department
Agri-Food & Veterinary Authority of Singapore
52 Jurong Gateway Road #14-01
Singapore 608550
Tel: +(65) 6805 2910
(Attention: Mr Cheng Chee Seng)
Email:
1 The Codex Alimentarius Commission is the international food standards setting body formed by the Food and Agriculture Organisation (FAO) and the World Health Organisation (WHO).