October 10, 2003

Embassy of the United States of America
Belgrade

NEW REGULATIONS ON FOOD SAFETY, PUBLIC HEALTH SECURITY AND BIOTERRORISM WILL IMPACT FOOD EXPORTERS TO THE U.S.

In mid-October the United States Food and Drug Administration (USFDA), which regulates food safety, plans to publish final regulations necessary to carry out major food safety provisions of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. These regulations will place new responsibilities on many companies and individuals in the food and animal feed industries. The specific responsibilities under the new regulations are as follows:

- Registration by December 12, 2003, of all domestic and foreign facilities that manufacture, process, pack or hold food for consumption by humans or animals in the U.S. An online registration system is under development and will be available once USFDA publishes the final rules. Registration by mail will also be possible at that time.

- Prior notice to USFDA of each article of food imported or offered for import into the U.S. before the food arrives at the port of entry. This requirement also takes effect on December 12, 2003. Importers, in most circumstances, will be able to provide the required information to USFDA using Customs and Border Protection’s automated commercial system, currently used to obtain import information required by customs.

- Creation and maintenance of records by domestic persons that manufacture, process, pack, transport, distribute, receive, hold, or import food for consumption in the U.S. that identify the immediate previous sources and the immediate subsequent recipients of food (i.e., where it came from and where it went). Foreign facilities that manufacture, process, pack or hold food for consumption in the U.S. also would have to comply with this requirement.

Exporters from Serbia and Montenegro of food and feed products should review the FDA's proposed regulations and forms which are in the process of being finalized. They can be found on the FDA web site at: www.fda.gov/oc/bioterrorism/bioact.html .

The key draft documents are the "Proposed Regulation - Prior Notice of Imported Food Shipments" and the draft "form" as well as the "Proposed Regulation - Registration of Food Facilities" and the draft "form" under this category. Any company comments should be sent to the Commercial Attaché at the Embassy of Serbia and Montenegro in Washington DC at: 202-332-0333.

10. oktobar 2003.

Ambasada Sjedinjenih Američkih Država
Beograd

NOVI PROPISI O BEZBEDNOSTI HRANE, ZDRAVSTVENOJ SIGURNOSTI I BIOTERORIZMU
UTICAĆE NA IZVOZNIKE HRANE U SAD

Sredinom oktobra Uprava za hranu i lekove SAD (USFDA), koja reguliše oblast bezbednosti hrane, palnira da objavi pravilnike u skladu sa osnovnim odredbama Akta o javnoj zdravstvenoj sigurnosti i Bioterorizmu iz 2002. godine. Ovi propisi definisaće nove odgovornosti mnogih kompanija i privatnih lica u industriji hrane za ljudsku i životinjsku upotrebu. Obaveze predviđene novim propisima su:

- Registracija do 12. decembra 2003. godine svih domaćih i stranih prehrambenih objekata u kojima se proizvodi, prerađuje, pakuje ili čuva hrana za ljudsku ili životinjsku prehranu u SAD. Onlajn sistem registracije preko Interneta je u fazi izrade i biće dostupan u trenutku objavljivanja novih propisa USFDA. Registracija poštom biće takođe omogućena.

- Podnošenje prethodnog obaveštenja USFDA-u o hrani uvezenoj ili namenjenoj uvozu u SAD, pre dopremanja hrane do mesta ulaska u SAD. Ova obaveza stupa na snagu takođe od 12. decembra 2003. godine. Uvoznicima, u većini slučajeva, omogućiće se upotreba automatizovanog trgovinskog sistema Carine i Granične inspekcije za podnošenje traženih informacija USFDA-u, koji trenutno koristi carinska služba za dobijanje bitnih informacija.

- Domaći subjekti koji se bave proizvodnjom, preradom, pakovanjem, transportom, distribucijom, primanjem, skladištenjem ili uvozom hrane za potrošnju u SAD-u biće u obavezi da izrade i čuvaju dokumentaciju koja je neophodna za utvrđivanje neposrednog izvora i krajnjeg primaoca hrane (to jest, odakle je hrana došla i gde je upućena). Ovaj zahtev se odnosi i na strane objekte u kojima se proizvodi, prerađuje, pakuje ili čuva hrana za potrošnju u SAD.

Izvoznici hrane za ljudsku i životinjsku upotrebu iz Srbije i Crne Gore treba da se upoznaju sa predloženim propisima i formularima američke Uprave za za hranu i lekove, koji su u završnoj fazi izrade i mogu se naći na FDA-ovoj web strani o bioterorizmu www.fda.gov/oc/bioterrorism/bioact.html .

Ključni predlozi dokumenata u ovoj oblasti su “Predlog Pravilnika – Prethodno obaveštavanje o isporukama hrane“ i predlog formulara, kao i “Predlog Pravilnika – Registracija prehrambenih objekata“ i predlog formulara za ovu kategoriju. Eventualni komentari zainteresovanih kompanija upućuju se Komercijalnom atašeu Ambasade Srbije i Crne Gore u Vašingtonu na tel: +202-332-0333.