Information labelling requirements

In the United States, additional ramifications maybe expected from FDA s announcement of final regulations for new food labeling requirements under the directive of the Nutrition Labeling and Education Act of 1990 (2). Among other things, these regulations limit health claims that can be made on food labels. They also require new information on nutrient content, and limit the use of descriptors such as low and free in association with calories, fat levels, and other food product characteristics. 

Includes radiation limits, prior approval, QA programmes, testing procedures, information/documentation requirements, and marking/labelling/placarding. 

Approved IVD tests are required to have standard product labeling. The current labeling requirements include provisions dealing with intended use(s), summary and explanation of test, information on specimen collection and preparation, procedures, results, limitations of the procedure, expected values, and specific performance characteristics. 

Furnish information about such architectural requirements as hardware functions, door closers, door opening assists, paint and finish, fire labeling requirements, etc. 

For consumer sales of additives sold as such, information similar to labelling particulars for foods generally is required, and for business sales of such additives specific requirements are set out in Directive 89/107/EEC. Labelling requirements for flavourings sold as such are contained in Directive 88/388/ EEC, completed by Directive 91/71/EEC.16... 

This book will give back the edge to the examination candidate if they digest its contents. It is crammed full of precise, clear and well-labelled diagrams. In addition, the explanations are well structured and leave the reader with a clear understanding of the main point of the diagram and any additional information where required. It is also crammed full of definitions and derivations that are very accessible. 

Labeling requirement No promotional material approval required after FDA approval for product marketing All promotional materials must be pre-approved Promotional materials are submitted to the FDA for information... 

Dietary Supplement Health and Education Act(1994) Established standards with respect to dietary supplements but prohibited full FDA review of supplements and botanicals as drugs. Required the establishment of specific ingredient and nutrition information labeling that defines dietary supplements and classifies them as part of the food supply but allows unregulated advertising. 

Sponsors of broadcast advertisements are also required to present a brief summary or, alternatively, may make adequate provision. .. for dissemination of the approved or permitted package labeling in connection with the broadcast presentation (21 CFR 202.1(e)(1)). This is referred to as the adequate provision requirement. The regulations thus specify that the major statement, together with adequate provision for dissemination of the product s approved labeling, can provide the information disclosure required for broadcast advertisements. 

This book is intended for chemists, toxicologists, laboratory technicians, manufacturers, safety professionals and government personnel involved in environmental and industrial safety and health matters. The ability to identify the actual manufacturers of hazardous materials is important where detailed background information is required when investigating chemical accidents, exposures, product contamination, faulty labeling and other incidents involving chemicals and their effect on workers or the environment. 

One of the advantages of purchasing a complete feed is that the label provides useful information, including a list of ingredients (in some countries a complete formula) and a guaranteed analysis. The following information is required by law on commercial poultry feed labels (complete feeds and supplements) in North America ... 

The labeling section of the monograph specifies what must be placed on a product label dose, directions for use, warnings, and all other information deemed essential for safe use by the general public. These labeling provisions must be combined with those label requirements already specified under general provisions. ... 

A recent monitoring and enforcement exercise across several EU countries identified that only 22% of chemical preparations are in full compliance with classification and labelling requirements [192]. About 20% of the errors for preparations were considered severe , which includes the incorrect labelling of carcinogens [192], Similar findings arose from a survey that examined substances. This study found that only 66% of substance safety data sheets31 (SDS) were available to companies and, of these, only 80% of SDS information, 75 % of classification and 58% of labelling proved to be correct [193]. 

For more detailed information about the USDA organic labeling requirements or information on how to become certified organic, visit the following Web sites ... 

Products which have not yet been packaged for the final consumer must be provided with a label and must be transported in closed packaging or containers sealed in a manner preventing substitution of the contents. In addition to the usual labelling requirements, the labelling must also contain the following information the name and address of the person responsible for the production or preparation of the product, the name of the product, and the code number of the inspection body. 

The system must provide the ability to print various inventory, sample, and pre- and post-dispensing labels. All labels should include a bar code and printed text with the pertinent batch and/or lot information. Labels must comply with GMP-GLP (good laboratory practices) requirements to meet the needs of both laboratories and clinical manufacturing. Labels should be available in multiple sizes to accommodate laboratory sample containers as well as production drums. 

The labelling requirements for Schedule D products are required to contain the following information on both the inner and outer labels ... 

After a positive decision in principle to approve the application, the Pharmaceutical Administration will determine the conditions for marketing (OTC, prescription-only medicine [POM], etc.) of the approved product, the contents of the patient insert, professional prescribing information and the label requirements and may set additional conditions regarding the marketing of the product. 

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