Clock ticking on regulatory reviews
The Food Regulation Standing Committee has released a food regulation discussion paper: Review Of FSANZ Assessment and Approval Processes and Treatment of Confidential Commercial Information.
As current Food Standards Australia New Zealand (FSANZ) processes are burdensome, the food manufacturing industry welcomes the prospect of change. This review provides the opportunity of challenging many elements of current processes. For example, the “one size fits all” approach to the assessment of applications and proposals requires review.
The assessment process could be matched to the degree of complexity and degree of risk of the application. Possibly 40 – 60% of applications could be processed with reduced work and minimal paperwork.
Also, there should be increased recognition of the regulatory situation overseas.
If an additive is approved in Europe, the US, Canada and Japan, this may be sound scientific reason to expedite Australian approval.
The ‘estimated likely time to complete an application’ presented in the discussion paper (page 25) shows that an applicant may expect to wait as long as 36.1 months for approval. Clearly, this is unacceptable. Increasing the FSANZ staff is not the answer.
The solution is provided by the introduction of improved, more efficient processes.
Cost recovery is intrinsically unfair.
For a large company, the payment represents a very small percentage of their turnover. For a small company, requiring a change to standard to enable a new product launch, the financial burden of a cost recovery payment is likely to be too high.
Industry has expressed concern that FSANZ may utilize “clock stop” provisions inappropriately where they wish to buy more time to consider an application, particularly for paid applications. This is frustrating, as a fee has been paid for a shortened timeframe.
The practice of Ministerial Council requesting review (currently in 23% of cases) results in lengthy delays. The question must be asked, “Why do jurisdictions on Council miss the opportunity to make submissions during the FSANZ standard development process?”
Perhaps the strongest motivation for change arises from Australia’s National Food Industry Strategy (NFIS) .
It is essential that we become better at food production and food processing through innovation if we are to compete on a ‘level playing field’ with other large food producing nations.
If a company, in the process of a planning an innovative product launch, requires a change to a food standard, the predicted time to approve this change is likely to threaten marketing plans and profit opportunities.
Paradoxically, the government’s promotion for innovation is stifled by the regulatory system. The challenge is to extensively change FSANZ processes. An outcome that makes peripheral changes must be avoided.
3-Aug-2005