Approved additives

In Europe, the formation of the European Economic Community has created a requirement to bring food additive approvals of the member nations into alignment, so as to eliminate differences in laws that hinder the movement of foodstuffs among these nations. Historically the member countries have differed widely in approaches to food additive approval and their tendency to approve new additives. At the time of this writing, a framework directive for food additives and several specific directives for various categories of additives are nearing completion (3). 

Other signatures may also be required. Eor example, if there are sub-eontraetors who will be performing site work, a representative from the subeontraeting firm should review and approve the plan. If the site has oversight eontraetors present, is eomplieated, large in size, or ineludes work that is projeeted to take plaee over a long period of time, there will likely be additional approvals required. 

Active substances BgVV and EU Food Contact Additive approved a Nitrate free... 

Absence of carcinogenity, genotoxicity, developmental and reproductive toxicity and of chronic toxicity effects at low exposure levels are indispensable prerequisites for food additive approvals. All substances approved in the European Union or the USA or deemed generally recognised as safe (GRAS) in the USA fulfil this requirement. 

The extent of safety studies necessary to obtain food additive approval can be demonstrated by the studies carried out on acesulfame K (trade name Sunett ), one of the sweeteners developed in course of the last 25 years,7 which has been endorsed for food use by the Joint Expert Committee on Food Additives (JECFA) of the WHO and FAO and the Scientific Committee for Foods (SCF) of the EU and has meanwhile been approved in more than 100 countries. This program shows the wide range of studies necessary. 

The applicability of bulk and intense sweeteners is determined by their regulatory status. Bulk and intense sweeteners require food additive approval in many countries. 

An important step and for some countries even a prerequisite before food additive approval is endorsement for food use by international scientific bodies like the JECFA or the European SCF. These committees evaluate the safety data, identify a no-observed-effect level and allocate an ADI, usually by applying a safety factor of 100 to the ADI. While numerical values have been allocated for all intense sweeteners, the ADIs for bulk sweeteners are normally not specified as any numerical limitation would not be reasonable for these substances. 

In the USA the available bulk sweeteners are listed under different provisions, like food additive, interim status, GRAS (Generally Recognised As Safe) or GRAS by self-determination or self-affirmation of the manufacturers. Intense sweeteners require food additive approval which includes a listing of the approved fields of use or may be a listing as a general purpose sweetener.32... 

The extensive safety studies necessary for food additive approval and the high cost of such studies are more or less prohibitive for the development of new sweeteners. Although some intensely sweet plant constituents have been considered for development, apparently only one new sweetener has undergone... 

The two technical houses are DDC and NTIS. DDC used to be AST1A. It handles classified or otherwise restricted documents and you must be registered there. This is important. If you are not registered, write for information but don t waste rime asking for documents. (Limited documents — numbers followed by the letter L — require additional approval by the issuing agency). NTIS used to be Clearinghouse. 

In the United States and the EU, obtaining food additive approval of a new excipient must be carefully evaluated. It can take many years to obtain approval for a new food additive. A GRAS determination may be a more practical method to ascertain the safety of a new excipient especially in the United States, because the determination of an ingredient as GRAS can be performed independent of a review by the FDA. 

In Europe, the formation of the European Economic Community has created a requirement to bring food additive approvals of the member nations into alignment, so as to eliminate differences in laws that hinder the movement of foodstuffs among these nations. 

The main intense sweeteners currently permitted for use in the major markets of Europe and the United States are not natural and have had to go through a food additive approval procedure. Within the European Union, approval is controlled by the EU Commission, with the aim of achieving harmonisation across member states. The current system allows for temporary national approval (and this was the mechanism by which sucralose was approved in the United Kingdom). This in turn allows the other EU countries time to review the data and either approve or reject each product within a specified period. Within the European Union, approved sweeteners are assigned an E number and can also be assigned a maximum use level within a specific application (e.g. soft drinks). The maximum use levels for sweeteners in soft drinks in the European Union are given in Table 4.2. 

Food and Drug Administration (FDA) approved the first clinical trial of MDMA (ecstasy) as a treatment for post-traumatic stress disorder (PTSD) in the United States. As of 2002 the proposed research waited for additional approvals. 

List of Some New Food Additives Approved to Use in Australia, Which can Potentially Cause Health Problems in Humans... 

The second-level supervisor or department head ensures that PSSR requirements have been addressed and documented in the PSSR Form. He may elect to secure additional approvals. His authorization signature (line 9) grants approval to start up the new or changed facilities. If any of the pre-startup requirements have not been met satisfactorily, he notifies the supervisor of the affected process unit to correct the deficiencies and repeat the Pre-Startup Safety Review. (Note Authorization to proceed with the change, completion of the PSSR, and approval for startup may occur at the same time for changes of a minor nature.)... 

Moxifloxacin hydrochloride was approved for the peroral treatment of AECB, CAP and ABS, and is also available as an infusion solution for the sequential treatment of CAP. In 2004, it was additionally approved by the FDA as the first intravenously and perorally administrable antibiotic for treating CAP, which is caused by multidrug-resistant S. pneumoniae (MDRSP). MDRSP is understood to include those strains of S. pneumoniae that are resistant to two or more of the following classes of antibiotics penicillins and second-generation cephalosporins such as cefuroxime, macrolides, tetracyclines and trimethoprim/sulfamethoxazole. 

Most countries have their own specific set of regulations concerning food and drug colorants based on local systems of additive approval. Because of these local evaluations, these regulations vary quite significantly and must be assessed when selecting colorants for target markets that include these countries. 

Wider range of patients than in NDA/PLA database Larger numbers of patients Active comparator study designs Supplemental efficacy studies Additional approvals in non-ICH countries Pharmacoepidemiology and pharmacoeconomics in particular healthcare environments Post-marketing commitments All of the above... 

In this special case, additional approval is needed from the national authorities overseeing radiation safety. For example, in the United Kingdom this is the Administration of Radioactive Substances Advisory Committee (ARSAC). Application to ARSAC only requires a summary of the study protocol, but a careful scientific justification of the amount of radiation employed and the number of subjects exposed. The EU Directive 97/43/EurATOM sets dose limits for healthy subjects and patients. 

GRAS. Abbreviation for generally recognized as safe, applied to food additives approved by the FDA. 

The product life of additives approved under the new Amendment will probably be longer for another reason, because where relatively small dollar markets are involved—in the neighborhood of 1,000,000—there may be no incentive or justification for the development of a less expensive or more effective substitute. 

It has now been modified to meet the requirements of a Canadian NGO with the appointment of directors instead of board members. The ICCIDD is now registered as a Canadian NGO with (in addition) approval as a charitable organization in Canada. The ICCIDD was indebted to Mr. Robin Ritchie, QC, Ottawa, for the necessary legal advice to make this transfer. 

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