FDA Releases Final Guidance for Voluntary Qualified Importer Program

The U.S. Food and Drug Administration is announcing final guidance for industry for a voluntary, fee-based program to allow the expedited review and importation of foods into the United States from importers with a proven track record of food safety and security. The final guidance is in question-and-answer format to explain how this program will work.

In particular the document address the following points:

  • The benefits VQIP importers can expect to receive;
  • The eligibility criteria for VQIP participation;
  • Instructions for completing a VQIP application;
  • Conditions that may result in revocation of participation in VQIP; and
  • Criteria for VQIP reinstatement following revocation.

The Food Safety Modernization Act (FSMA), indeed, required FDA to establish a voluntary, fee-based program for the expedited review and importation of foods from importers who achieve and maintain a high level of control over the safety and security of their supply chains. This control includes importation of food from facilities that have been certified in accordance with FDA’s program for Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications (see FDA’s third-party certification regulations at 21 CFR part 1, subpart M), as well as other measures that support a high level of confidence in the safety and security of the food they import. Expedited entry incentivizes importers to adopt a robust system of supply chain management and further benefits public health by allowing FDA to focus its resources on food entries that pose a higher risk to public health.

Speaking of benefits for companies, they will be the following:

• FDA will expedite entry into the United States for all foods included in an approved VQIP application (VQIP foods). FDA will set screening in its Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting (PREDICT) import screening system to recognize shipments of food which are the subject of an approved VQIP application to expedite the entry of such food. The system is designed to recognize the information and release the shipment immediately after the receipt of entry information, unless examination and sampling are necessary for public health reasons. (See Question A.5.)

• FDA will limit examination and/or sampling of VQIP food entries to “for cause” situations (i.e., when the food is or may be associated with a risk to the public health), to obtain statistically necessary risk-based microbiological samples, and to audit VQIP. (See Question A.5.)

• In the examination and/or sampling circumstances identified in the previous bullet, FDA will attempt, to the extent possible, to examine an entry and collect samples at the VQIP food destination or other location preferred by the VQIP importer. If exportation is warranted, FDA will assist in fulfilling an importer’s request to U.S. Customs and Border Protection (CBP) to export from the port preferred by the importer.

• FDA will expedite its laboratory analysis of “for cause” or audit samples of VQIP entries, to the extent possible in accordance with public health priorities.

• FDA will maintain a VQIP Importers Help Desk dedicated to responding to questions and resolving issues raised by VQIP importers about VQIP food and this guidance document. The VQIP Importers Help Desk will be available for assistance with completing the VQIP application and facilitating review of VQIP food that does not receive an immediate release.

• FDA will post a publicly available list of approved VQIP importers on FDA’s VQIP Web page. VQIP importers may choose not to be listed on the VQIP importers list. A VQIP importer’s decision to opt out of being listed on the publicly available list of approved VQIP importers will not have any effect on its participation.

Additional Information

 

China and wine: the new norm on terminology translation of imported wine terms

I receive and gladly publish an extremely interesting article by Mariagrazia Semprebon – AgriLegal Consulting. Thanks Mariagrazia!

Many wine companies look eagerly forward to the Chinese market.

By now it is clear that there are some difficulties to penetrate the Chinese wine market and also some critical issues, but with ta good partner and some important preventive measures, it is possible to obtain great satisfactions.

One of the obvious trouble for the exporter is the language, the commercial communication barrier, that risks to cause mischievous misunderstanding.

First of all, the exporter company must translate his commercial name in Chinese characters, otherwise the importer or the Chinese consumer would transliterate the name of the brand in his place (and with little if no care at all).

In addition, it is important to match the brand with Protected Designation of Origin (PDO), Protected Geographical Indication (PGI), after ensuring the legitimacy of the indication according to Chinese laws.

It is also important:

– to clearly identify which is which among the product brand, its origin and the designation of origin – to translate it in order to made it clear to Chinese consumers where the product comes from.

The strength of a collective brand is in fact more incisive when consistently translated in the language of a country with a potential and strong developing market.

To prevent confusion and mistakes and to promote the Chinese wine market advancement, the Chinese government has drafted a standard document which includes many Italian and foreign wine terms translated in Chinese, and also some import regulations.

The Chinese Chamber of Commerce, the Agricultural Institute and its Wine Academy have completed an official guide on the matter.

The “Norm of Terminology Translation of Imported Wines”, 进口葡萄酒相关术语翻译规范, was enacted by the Chinese Ministry of Internal Trade and came into force on 1st September 2015.

It is applicable to all wine businesses which want to export in China.

This “Norm” is the first of its kind in the Chinese wine market, before there were only translation guidelines granted from wine commercial authorities.

The translated terms mainly concern wine grapes types, the most important wine regions and the biggest wine companies of the eleven examined producing countries.

It is structured as a table, according to the English alphabetic order and it is divided into four parts:

– the first chapter concerns norms;

– the second chapter includes label terminology;

– the third chapter involves the fundamental global wine grapes varieties (excluding China), with the type name, the origin country and the grapes color;

– the fourth and last chapter includes the most important wine region and wine cellars, with the name of the main producers.

This is not a binding transliteration, the operator is still free to choose his favorite translation, but it is clear that the standard, once adopted and legitimated, will be asserted by the Chinese government.

It is presumable that this standard translation will spread soon across the wine sector and, consequently, it will be convenient to comply with it to communicate more incisively.

Another fact must be bear in mind, and is that the Chinese names suggested by the guide are not made up by the Chinese Chamber of Commerce, they were already present on the Chinese market from long time, and have been gathered in the “Norm”.

After the implementation of the “Norm of Terminology Translation of Imported Wines”, the Chinese names included in the list will be, probably, adopted by distributors, importers and also from media.

The “Norm of Terminology Translation of Imported Wines” is a perfect instrument for the wine maker, that still does not have registered his brand in China, to verify if his brand transliteration correspond to the one proposed by the guide and to orient himself into the Chinese market.

To the producers who have a Chinese registered brand it is possible to adjust it according to the new norm, or also to try to integrate it into this new norm, when revised.

The Chinese Ministry of Commerce has in fact declared that it will be possible to revise the guide after September 2018 (the Chinese Ministry of Commerce regulation provides in fact that a standard can be modified after three years from its publication to follow market innovations and new technologies).

In the prospect of the seen revision wine cellars, which have a registered brand in China and want to put into the norm of terminology translation (as Zenato has already done), could ask for the integration of their name in the guide.

There are some other advices for wine makers who intend to enter the Chinese market, once transliterated the name of their brands and the product information according to the norm, it is important to register the brand also in China.

Before to do it, it is necessary to control if the brand is already registered or filed in China by somebody else.

If so, wine cellar can claim its brand before a Chinese court but it is an expensive way, it could be better even to consider to change the brand name to some extension for the Chinese market.

What is absolutely to avoid is to register or simply introduce in China a brand without a comprehensive research on the potential prior use of the same brand in the Chinese market, because it can expose the producer to the risk of legal challenges in China.

Finally, the brand registration should not be limited to continental China, but it should include also Taiwan, Hong Kong and Macao.

In the end, to commerce in the Chinese market, it is better not only to take into consideration big cities as Bejing or Shangai, but also think about other areas, for example the so-called “food capital” of China: Guangzhou.

Click here for the Norm.

Linked below are some related articles:

http://www.novagraaf.com/en/news?newspath=/NewsItems/en/wineries-face-new-norm-china

http://www.decanterchina.com/en/?article=1017

http://www.ilfattoalimentare.it/vini-in-cina-mercato.html

A book (available on Amazon) on a conference about wine and China held in 2014 in Montepulciano:

http://www.amazon.it/Il-vino-Cina-conference-Bilingual-ebook/dp/B00JUL31OM