Thank you for your timely response Mr. Yong.
For Item #1. Its so happen that there were no published local regulations applicable for our product. As the standard suggest, in the absence of local regulation you may refer to internationally recognised/accepted regulation.
See below the statement of findings.
The process of updating the preliminary information following the establishment of OPRP and/or the HACCP Plan was not adequately demonstrated:
- Update on the Regulation (EU) 2016/ 1416 amendment to EU No 10/2011 was recognized by the Plant on October 2016, namely “Addition of migration limit for Aluminum (1mg/ kg food) and Zinc Migration was reduced to 5 mg/kg”.. However such update was not captured in the Raw Material Description for PE Film (Direct Product Contact) particularly on the chemical characteristic relevant for food safety, (Appendix 2, Version 3, Eff. Date: Feb. 16, 2015).
Note: 3rd party analysis related to the above showed passing results.
- End Product Description, Appendix 3, Version 2, Eff. Date: Nov. 3, 2014, showed the applicable regulation for raw materials such as Adhesive (21 CFR 175.105), and Resin (21 CFR 177.1520). However specific requirement related to the above, was not clearly identified.
All the best,
hi Mr Devesa,
afaik, fssc do not care what source is used to support yr chosen CCP/oprp methodology of distinction. afaik no regulatory procedures exist anywhere.
This looks more like a criticism of the product specification or a PRP related program. The former could relate to Yong's comment but if non-existent the choice would then first shift to intended location of usage. Is this the EC ? If only local the choice is presumably up-to-you (IMEX many countries simply refer to some particular international system of limits).
Which specific clause of the fssc standard(s) was referenced ?
Why not simply update the specification (if that is the problem) ?
Sorry if i have not fully understood the difficulty.