No objection letter

This powerpoint presentation reviews food-contact regulations worldwide with reference to current systems for regulating food-contact materials. These include general safety requirements, licensing/registration, mandatory and voluntary positive lists, no objection letters, and combinations of the above and their applicability to various countries. 

USFDA No objection letters United States Food and Drugs Agency, Washington, DC. 

The use of PCR material for food contact packaging involves a governmental approval of the recycling process ability to decontaminate the material. In the USA, it takes the form of a no objection letter (NOL) being issued by the FDA after reviewing submitted data of decontamination. The FDA lists about 125 NOL, all but a few are for PET. The first PET NOL was issued in 1991 to Hoechst Celanese, an early supplier of PET resin. 

Legality Not legal until a regulation is published Legal if the Agency has no objections after the 120 day review period Not legal until letter is received... 

These processes for PET yield materials that can be used interchangeably with virgin PET, and several companies have received letters of no objection for these processes. 

Doctor Smith, you say, asks what is the best elementary book on the principles of government. None in the world equal to the Review of Montesquieu, printed at Philadelphia a few years ago. It has the advantage, too, of being equally sound and corrective of the principles of political economy and all within the compass of a thin 8vo. Chipman s and Priestley s Principles of Government, and the Federalists, are excellent in many respects, but for fundamental principles not comparable to the Review, I have no objections to the printing my letter to Mr, Carr, if it will promote the interests of science although it was not written with a view to its publication. 

In Canada and the United States, the food additive petition processes are similar and require premarket review and approval. In the United States, under the proposed GRAS Notification rule, a manufacturer can declare that a substance is GRAS if there is scientific consensus among qualified experts about its safety under the conditions of intended use. The manufacturer then notifies FDA, and if the agency has no questions, a letter of no objection is issued. 

By contrast, the GRAS Notification process requires that the manufacturer make the initial declaration of the safety of the product based on consensus by qualified experts. FDA then reviews the notification and, if all of its questions are satisfactorily answered, the agency issues a letter of no objection. Because this process has become the primary route of introduction of new ingredients to infant formulas, the GRAS Notification process is reviewed in greater detail in Chapter 4. 

The regulatory agency would review the panel s safety assessment and other data in the submission and if satisfied, would issue a letter of no objection. If the regulatory agency has questions and the manufacturer does not answer them satisfactorily, the agency can reject the submission, ask the company to withdraw it, or suggest consultation with additional experts qualified to opine on the specific safety concerns. 

In 1991, Goodyear obtained a letter of no objection from the U.S. PDA for the use of its Repete tertiary recycled PET in food contact applications. The process, later sold to... 

Monsanto, like many chemical firms, had a product safety program in place long before passage of TSCA. The Monsanto program from its inception embraced the spirit and in many cases the letter of what later appeared as the law. In some situations TSCA has improved the focus of Monsanto s information management and has been beneficial. In other cases we have provided constructive criticism of EPA proposed rules which required information submission and management with no specific objective. 

To the Editor I should like to reply to Dr. Thomas Perry s letter published June 18, 1970. Dr. Perry s objections are well intentioned there is no doubt. He is concerned about our inappropriate and immoral national policies. He is concerned about potential misuse of scientific information for purposes other than the good of mankind. How can anyone disagree Yet his approach will not serve to implement any real change in the basis for these concerns. If we contemplate changing the course of our nation, must we not direct our efforts toward those capable of seeing that a change takes place ... 

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