natgillin/translations-raw huggingface dataset:
CAS No.: 85-68-7
Direktiva 2001/83/EZ Europskog parlamenta i Vijeća od 6. studenoga 2001. o zakoniku Zajednice o lijekovima za humanu primjenu (SL L 311, 28.11.2001., str. 67.).
EC No.: 201-622-7
PRILOG
Diisobutyl phthalate (DIBP)
Unos 51.
CAS No.: 84-69-5
Priloga XVII.
EC No.: 201-553-2
Uredbi (EZ) br. 1907/2006 zamjenjuje se sljedećim:
Shall not be used as substances or in mixtures, individually or in any combination of the phthalates listed in column 1 of this entry, in a concentration equal to or greater than 0,1 % by weight of the plasticised material, in toys and childcare articles.
Bis(2-etilheksil)-ftalat (DEHP)
Shall not be placed on the market in toys or childcare articles, individually or in any combination of the first three phthalates listed in column 1 of this entry, in a concentration equal to or greater than 0,1 % by weight of the plasticised material.
CAS br.
In addition, DIBP shall not be placed on the market after 7 July 2020 in toys or childcare articles, individually or in any combination with the first three phthalates listed in column 1 of this entry, in a concentration equal to or greater than 0,1 % by weight of the plasticised material.
117-81-7
Shall not be placed on the market after 7 July 2020 in articles, individually or in any combination of the phthalates listed in column 1 of this entry, in a concentration equal to or greater than 0,1 % by weight of the plasticised material in the article.
EZ br.
Paragraph 3 shall not apply to:
204-211-0
articles exclusively for industrial or agricultural use, or for use exclusively in the open air, provided that no plasticised material comes into contact with human mucous membranes or into prolonged contact with human skin;
Dibutil-ftalat (DBP)
aircraft, placed on the market before 7 January 2024, or articles, whenever placed on the market, for use exclusively in the maintenance or repair of those aircraft, where those articles are essential for the safety and airworthiness of the aircraft;
CAS br.
motor vehicles within the scope of Directive 2007/46/EC, placed on the market before 7 January 2024, or articles, whenever placed on the market, for use exclusively in the maintenance or repair of those vehicles, where the vehicles cannot function as intended without those articles;
84-74-2
articles placed on the market before 7 July 2020;
EZ br.
measuring devices for laboratory use, or parts thereof;
201-557-4
materials and articles intended to come into contact with food within the scope of Regulation (EC) No 1935/2004 or Commission Regulation (EU) No 10/2011;
Benzil-butil-ftalat (BBP)
medical devices within the scope of Directives 90/385/EEC, 93/42/EEC or 98/79/EC, or parts thereof;
CAS br.
electrical and electronic equipment within the scope of Directive 2011/65/EU;
85-68-7
the immediate packaging of medicinal products within the scope of Regulation (EC) No 726/2004, Directive 2001/82/EC or Directive 2001/83/EC;
EZ br.
toys and childcare articles covered by paragraphs 1 or 2.
201-622-7
For the purposes of paragraphs 1, 2, 3 and 4(a),
Diizobutil-ftalat (DIBP)
‘plasticised material’ means any of the following homogeneous materials:
CAS br.
polyvinyl chloride (PVC), polyvinylidene chloride (PVDC),polyvinyl acetate (PVA), polyurethanes,
84-69-5
any other polymer (including, inter alia, polymer foams and rubber material) except silicone rubber and natural latex coatings,
EZ br.
surface coatings, non-slip coatings, finishes, decals, printed designs,
201-553-2
adhesives, sealants, paints and inks.
Ne smiju se koristiti kao tvari ili u smjesama, pojedinačno ili u bilo kojoj kombinaciji ftalata iz prvog stupca ovog unosa, u koncentraciji koja je jednaka ili veća od 0,1 % masenog udjela plastificiranog materijala, u igračkama i proizvodima za skrb o djeci.
‘prolonged contact with human skin’ means continuous contact of more than 10 minutes duration or intermittent contact over a period of 30 minutes, per day.
Ne smiju se stavljati na tržište u igračkama ili proizvodima za skrb o djeci, pojedinačno ili u bilo kojoj kombinaciji prva tri ftalata iz prvog stupca ovog unosa, u koncentraciji koja je jednaka ili veća od 0,1 % masenog udjela plastificiranog materijala.
‘childcare article’ shall mean any product intended to facilitate sleep, relaxation, hygiene, the feeding of children or sucking on the part of children.
Osim toga, DIBP ne smije se stavljati na tržište nakon 7. srpnja 2020. u igračkama ili proizvodima za skrb o djeci, pojedinačno ili u bilo kojoj kombinaciji s prva tri ftalata iz prvog stupca ovog unosa, u koncentraciji koja je jednaka ili veća od 0,1 % masenog udjela plastificiranog materijala.
For the purposes of paragraph 4(b), ‘aircraft’ means one of the following:
Ne smiju se stavljati na tržište nakon 7. srpnja 2020. u proizvodima, pojedinačno ili u bilo kojoj kombinaciji ftalata iz prvog stupca ovog unosa, u koncentraciji koja je jednaka ili veća od 0,1 % masenog udjela plastificiranog materijala u proizvodu.
a civil aircraft produced in accordance with a type certificate issued under Regulation (EC) No 216/2008 or with a design approval issued under the national regulations of a contracting State of the International Civil Aviation Organisation (ICAO), or for which a certificate of airworthiness has been issued by an ICAO contracting State under Annex 8 to the Convention on International Civil Aviation, signed on December 7, 1944 , in Chicago;
4.
a military aircraft.
Stavak 3. ne primjenjuje se na:
Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food (OJ L 12, 15.1.2011, p. 1).’
proizvode isključivo za industrijsku ili poljoprivrednu uporabu, ili za uporabu isključivo na otvorenom, pod uvjetom da nikakvi plastificirani materijali ne dolaze u dodir sa sluznicom ljudi ili u dulji dodir s ljudskom kožom;
https://echa.europa.eu/previous-consultations-on-restriction-proposals/-/substance-rev/13919/term
motorna vozila obuhvaćena područjem primjene Direktive 2007/46/EZ koja su stavljena na tržište prije 7. siječnja 2024. ili proizvode, neovisno o tome kad su stavljeni na tržište, koji se upotrebljavaju isključivo za održavanje ili popravak tih vozila, ako vozila ne mogu funkcionirati kako je predviđeno bez tih proizvoda;
authorising the placing on the market of decorticated grains of Digitaria exilis as a traditional food from a third country under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470
o odobravanju stavljanja na tržište oljuštenih zrna biljke Digitaria exilis kao tradicionalne hrane iz treće zemlje u skladu s Uredbom (EU) 2015/2283 Europskog parlamenta i Vijeća i o izmjeni Provedbene uredbe Komisije (EU) 2017/2470
Having regard to Regulation (EU) No 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 and Commission Regulation (EC) No 1852/2001, and in particular Article 15(4) thereof,
uzimajući u obzir Uredbu (EU) br. 2015/2283 Europskog parlamenta i Vijeća od 25. studenoga 2015. o novoj hrani, o izmjeni Uredbe (EU) br. 1169/2011 Europskog parlamenta i Vijeća i o stavljanju izvan snage Uredbe (EZ) br. 258/97 i Uredbe Komisije (EZ) br. 1852/2001, a posebno njezin članak 15. stavak 4.,
Pursuant to Article 8 of Regulation (EU) 2015/2283, Commission Implementing Regulation (EU) 2017/2470 establishing a Union list of authorised novel foods was adopted.
Uredbe (EU) 2015/2283.
On 23 January 2018, the company Obà Food Srl.
Uredbe (EU) 2015/2283 donesena je Provedbena uredba Komisije (EU) 2017/2470 kojom je utvrđen Unijin popis odobrene nove hrane.
(‘the applicant’) submitted a notification to the Commission of the intention to place decorticated grains of Digitaria exilis (Kippist) Stapf (‘Fonio’) on the Union market as a traditional food from a third country within the meaning of Article 14 of Regulation (EU) 2015/2283.
U skladu s člankom 15. stavkom 4.
The applicant requests for decorticated grains of Digitaria exilis (Kippist) Stapf to be consumed as such or as a food ingredient by the general population.
Uredbe (EU) 2015/2283 Komisija odlučuje o odobravanju i stavljanju tradicionalne hrane iz treće zemlje na tržište Unije.
The documented data, presented by the applicant, demonstrate that decorticated grains of Digitaria exilis (Kippist) Stapf have a history of safe food use in West African countries, in particular Guinea, Nigeria and Mali.
Trgovačko društvo Obà Food Srl.
Pursuant to Article 15(1) of Regulation (EU) 2015/2283, on 28 February 2018, the Commission forwarded the valid notification to the Member States and to the European Food Safety Authority (‘the Authority’).
(„podnositelj zahtjeva”) 23. siječnja 2018. dostavilo je Komisiji obavijest o namjeri stavljanja na tržište u Uniji oljuštenih zrna biljke Digitaria exilis (Kippist) Stapf („fonio”) kao tradicionalne hrane iz treće zemlje u smislu članka 14.
No duly reasoned safety objections to the placing on the market within the Union of decorticated grains of Digitaria exilis (Kippist) Stapf were submitted to the Commission by Member States or the Authority within the four-month period laid down in Article 15(2) of Regulation (EU) 2015/2283.
Uredbe (EU) 2015/2283.
The Commission should therefore authorise the placing on the market within the Union of decorticated grains of Digitaria exilis (Kippist) Stapf and update the Union list of novel foods.
Podnositelj zahtjeva tvrdi da opća populacija može konzumirati oljuštena zrna biljke Digitaria exilis (Kippist) Stapf kao takva ili kao sastojak hrane.
Implementing Regulation (EU) 2017/2470 should therefore be amended accordingly,
Dokumentirani podaci koje je dostavio podnositelj zahtjeva pokazuju da oljuštena zrna biljke Digitaria exilis (Kippist) Stapf imaju povijest sigurne upotrebe za hranu u zapadnoafričkim zemljama, konkretno u Gvineji, Nigeriji i Maliju.
HAS ADOPTED THIS REGULATION:
U skladu s člankom 15. stavkom 1.
Article 1
Uredbe (EU) 2015/2283 Komisija je 28. veljače 2018. proslijedila valjanu obavijest državama članicama i Europskoj agenciji za sigurnost hrane („Agencija”).
Decorticated grains of Digitaria exilis (Kippist) Stapf as specified in the Annex to this Regulation shall be included in the Union list of authorised novel foods established in Implementing Regulation (EU) 2017/2470.
U roku od četiri mjeseca utvrđenom u članku 15. stavku 2.
The entry in the Union list referred to in paragraph 1 shall include the conditions of use and labelling requirements laid down in the Annex to this Regulation
Uredbe (EU) 2015/2283 ni države članice ni Agencija Komisiji nisu dostavile propisno obrazložene prigovore na sigurnost stavljanja na tržište u Uniji oljuštenih zrna biljke Digitaria exilis (Kippist) Stapf.
Article 2
Komisija bi stoga trebala odobriti stavljanje na tržište u Uniji oljuštenih zrna biljke Digitaria exilis (Kippist) Stapf i ažurirati Unijin popis nove hrane.
The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.
Provedbenu uredbu (EU) 2017/2470 trebalo bi stoga na odgovarajući način izmijeniti,
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Oljuštena zrna biljke Digitaria exilis (Kippist) Stapf, kako su specificirana u Prilogu ovoj Uredbi, uvrštavaju se na Unijin popis odobrene nove hrane utvrđen u Provedbenoj uredbi (EU) 2017/2470.
Done at Brussels, 18 December 2018.
Unos na Unijin popis iz stavka 1. uključuje uvjete upotrebe i zahtjeve za označivanje utvrđene u Prilogu ovoj Uredbi.
OJ L 327, 11.12.2015, p. 1.
Članak 3.
The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:
Sastavljeno u Bruxellesu 18. prosinca 2018.
Additional specific labelling requirements
Provedbena uredba Komisije (EU) 2017/2470 оd 20. prosinca 2017. o utvrđivanju Unijina popisa nove hrane u skladu s Uredbom (EU) 2015/2283 Europskog parlamenta i Vijeća o novoj hrani (SL L 351, 30.12.2017., str. 72.).
‘Decorticated grains of Digitaria exilis (Kippist) Stapf
Prilog Provedbenoj uredbi (EU) 2017/2470 mijenja se kako slijedi:
(Traditional food from a third country)
Sljedeći unos umeće se abecednim redom u tablicu 1.
Not specified
(Odobrena nova hrana):
The designation of the novel food on the labelling of the foodstuffs containing it shall be “decorticated fonio (Digitaria exilis) grains”’
Odobrena nova hrana
The following entry is inserted in Table 2 (Specifications) in alphabetical order:
Uvjeti pod kojima se nova hrana može upotrebljavati
‘Decorticated grains of Digitaria exilis (Kippist) Stapf (fonio)
„Oljuštena zrna biljke Digitaria exilis (Kippist) Stapf
Description/Definition
(tradicionalna hrana iz treće zemlje)
The traditional food is the decorticated grain (bran removed) of Digitaria exilis (Kippist) Stapf.
Nije određeno
Digitaria exilis (Kippist) Stapf) is an annual herbaceous plant belonging to the Poaceae family.
Pri označivanju hrane koja sadržava novu hranu navodi se „oljuštena zrna fonija (Digitaria exilis)””
Typical nutritional components of decorticated grain of fonio
Sljedeći unos umeće se abecednim redom u tablicu 2.
Carbohydrates: 76,1 g/100 g of fonio
(Specifikacije):
Water: 12,4 g/100 g of fonio
Odobrena nova hrana
Protein: 6,9 g/100 g of fonio
Specifikacija
Fat: 1,2 g/100 g of fonio
„Oljuštena zrna biljke Digitaria exilis (Kippist) Stapf (fonio)
Fibre: 2,2 g/100 g of fonio
Opis/definicija:
Ash: 1,2 g/100 g of fonio
Tradicionalna hrana su oljuštena zrna (bez mekinja) biljke Digitaria exilis (Kippist) Stapf.
Phytate content: ≤ 2,1 mg/g’
Digitaria exilis (Kippist) Stapf jednogodišnja je zeljasta biljka iz porodice Poaceae.
authorising the placing on the market of syrup from Sorghum bicolor (L.)
o odobravanju stavljanja na tržište sirupa od biljke Sorghum bicolor (L.)
Moench as a traditional food from a third country under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470
Moench kao tradicionalne hrane iz treće zemlje u skladu s Uredbom (EU) 2015/2283 Europskog parlamenta i Vijeća i o izmjeni Provedbene uredbe Komisije (EU) 2017/2470
Having regard to Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 and Commission Regulation (EC) No 1852/2001, and in particular Article 15(4) thereof,
uzimajući u obzir Uredbu (EU) 2015/2283 Europskog parlamenta i Vijeća od 25. studenoga 2015. o novoj hrani, o izmjeni Uredbe (EU) br. 1169/2011 Europskog parlamenta i Vijeća i o stavljanju izvan snage Uredbe (EZ) br. 258/97 i Uredbe Komisije (EZ) br. 1852/2001, a posebno njezin članak 15. stavak 4.,
Pursuant to Article 8 of Regulation (EU) 2015/2283, the Commission Implementing Regulation (EU) 2017/2470 establishing a Union list of authorised novel foods was adopted.
Uredbe (EU) 2015/2283.
(‘the applicant’) submitted a notification to the Commission of the intention to place syrup from Sorghum bicolor (L.)
U skladu s člankom 15. stavkom 4.
Moench on the Union market as a traditional food from a third country within the meaning of Article 14 of Regulation (EU) 2015/2283.
Uredbe (EU) 2015/2283 Komisija odlučuje o odobravanju i stavljanju tradicionalne hrane iz treće zemlje na tržište Unije.
The applicant requests for the authorisation for syrup from Sorghum bicolor (L.)
Trgovačko društvo Sorghum Zrt.
Moench to be consumed as such or to be used as a food ingredient by the general population.
Podnositelj zahtjeva tvrdi da sirup od biljke Sorghum bicolor (L.)
The documented data, presented by the applicant, demonstrate that syrup from Sorghum bicolor (L.)
Moench kao takav ili kao sastojak hrane može konzumirati opća populacija.
Moench have a history of safe food use in the United States.
Dokumentirani podaci koje je dostavio podnositelj zahtjeva pokazuju da sirup od biljke Sorghum bicolor (L.)
Pursuant to Article 15(1) of Regulation (EU) 2015/2283, on 30 April 2018, the Commission forwarded the valid notification to the Member States and to the European Food Safety Authority (‘the Authority’).
Moench ima povijest sigurne upotrebe za hranu u Sjedinjenim Američkim Državama.
No duly reasoned safety objections to the placing on the market within the Union of syrup from Sorghum bicolor (L.)
U skladu s člankom 15. stavkom 1.
Moench were submitted to the Commission by Member States or the Authority within the four-month period laid down in Article 15(2) of Regulation (EU) 2015/2283.
Uredbe (EU) 2015/2283 Komisija je 30. travnja 2018. proslijedila valjanu obavijest državama članicama i Europskoj agenciji za sigurnost hrane („Agencija”).
The Commission should therefore authorise the placing on the market within the Union of syrup from Sorghum bicolor (L.)
U roku od četiri mjeseca utvrđenom u članku 15. stavku 2.
Moench and update the Union list of novel foods.
Uredbe (EU) 2015/2283 ni države članice ni Agencija Komisiji nisu dostavile propisno obrazložene prigovore na sigurnost stavljanja na tržište u Uniji sirupa od biljke Sorghum bicolor (L.)
Implementing Regulation (EU) 2017/2470 should therefore be amended accordingly,
Moench.
HAS ADOPTED THIS REGULATION:
Komisija bi stoga trebala odobriti stavljanje na tržište u Uniji sirupa od biljke Sorghum bicolor (L.)
Article 1
Moench i ažurirati Unijin popis nove hrane.
Syrup from Sorghum bicolor (L.)
Provedbenu uredbu (EU) 2017/2470 trebalo bi stoga na odgovarajući način izmijeniti,
Moench as specified in the Annex to this Regulation shall be included in the Union list of authorised novel foods established in Implementing Regulation (EU) 2017/2470.
DONIJELA JE OVU UREDBU:
The entry in the Union list referred to in paragraph 1 shall include the conditions of use and labelling requirements laid down in the Annex to this Regulation.
Članak 1.
Article 2
Sirup od biljke Sorghum bicolor (L.)
The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.
Moench, kako je specificiran u Prilogu ovoj Uredbi, uvrštava se na Unijin popis odobrene nove hrane utvrđen u Provedbenoj uredbi (EU) 2017/2470.
Article 3
Unos na Unijin popis iz stavka 1. uključuje uvjete upotrebe i zahtjeve za označivanje utvrđene u Prilogu ovoj Uredbi.
Done at Brussels, 18 December 2018.
Članak 3.
OJ L 327, 11.12.2015, p. 1.
Sastavljeno u Bruxellesu 18. prosinca 2018.
Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods (OJ L 351, 30.12.2017, p. 72).
Za Komisiju
The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:
SL L 327, 11.12.2015., str. 1.
Authorised novel food
PRILOG
Conditions under which the novel food may be used
Prilog Provedbenoj uredbi (EU) 2017/2470 mijenja se kako slijedi:
Additional specific labelling requirements
Sljedeći unos umeće se abecednim redom u tablicu 1.
Other requirements
(Odobrena nova hrana):
‘Syrup from Sorghum bicolor (L.)
Odobrena nova hrana
Moench
Uvjeti pod kojima se nova hrana može upotrebljavati
(Traditional food from a third country)
Dodatni posebni zahtjevi za označivanje proizvoda
Not specified
Ostali zahtjevi
The designation of the novel food on the labelling of the foodstuffs containing it shall be “Sorghum (Sorghum bicolor) syrup”’.
„Sirup od biljke Sorghum bicolor (L.)
The following entry is inserted in Table 2 (Specifications) in alphabetical order:
Moench
Authorised Novel Food
(tradicionalna hrana iz treće zemlje)
Specifications
Nije određeno
Moench.
Sljedeći unos umeće se abecednim redom u tablicu 2.
laying down specific rules concerning the procedure to be followed in order to carry out the risk assessment of high risk plants, plant products and other objects within the meaning of Article 42(1) of Regulation (EU) 2016/2031 of the European Parliament and of the Council
o utvrđivanju posebnih pravila u vezi s postupkom koji treba slijediti kako bi se provela procjena rizika visokorizičnog bilja, biljnih proizvoda i drugih predmeta u smislu članka 42. stavka 1.
THE EUROPEAN COMMISSION,
Uredbe (EU) 2016/2031 Europskog parlamenta i Vijeća
Having regard to Regulation (EU) 2016/2031 of the European Parliament and of the Council of 26 October 2016 on protective measures against pests of plants, amending Regulations (EU) No 228/2013, (EU) No 652/2014 and (EU) No 1143/2014 of the European Parliament and of the Council and repealing Council Directives 69/464/EEC, 74/647/EEC, 93/85/EEC, 98/57/EC, 2000/29/EC, 2006/91/EC and 2007/33/EC, and in particular Article 42(6) thereof,
uzimajući u obzir Ugovor o funkcioniranju Europske unije,
Whereas:
uzimajući u obzir Uredbu (EU) 2016/2031 Europskog parlamenta i Vijeća od 26. listopada 2016. o zaštitnim mjerama protiv organizama štetnih za bilje i o izmjeni uredaba (EU) br. 228/2013, (EU) br. 652/2014 i (EU) br. 1143/2014 Europskog parlamenta i Vijeća te stavljanju izvan snage direktiva Vijeća 69/464/EEZ, 74/647/EEZ, 93/85/EEZ, 98/57/EZ, 2000/29/EZ, 2006/91/EZ i 2007/33/EZ, a posebno njezin članak 42. stavak 6.,
Rules should be established to ensure that the risk assessment referred to in Article 42(4) of Regulation (EU) 2016/2031 is conducted within a reasonable period of time and on the basis of a timely processing of technical dossiers.
budući da:
This would be necessary for the credibility and justification of the risk assessment as a basis of measures taken pursuant to Article 42(4) of Regulation (EU) 2016/2031.
To je nužno kako bi se osiguralo da su svi elementi potrebni za procjenu rizika povezanog s biljem, biljnim proizvodima ili drugim predmetima koji se unose na područje Unije certificirani od strane nadležnog javnog tijela treće zemlje, što je potrebno kako bi se osigurala vjerodostojnost i opravdanost procjene rizika kao temelja za mjere poduzete u skladu s člankom 42. stavkom 4.
Those provisions should apply without prejudice to the right of the Commission to submit requests to the European Food Safety Authority (EFSA) to issue scientific opinions pursuant to Article 29 and provide scientific or technical assistance pursuant to Article 31 of Regulation (EC) No 178/2002 of the European Parliament and of the Council.
Uredbe (EU) 2016/2031.
The technical dossier should contain data on the commodities to be introduced into the territory of the Union, as well as data on the identification of pests potentially associated with the commodity in the exporting country, data on national phytosanitary mitigation measures, inspections and treatments and processing of the commodity and contact details of the natural person responsible for liaising with the Commission and EFSA.
Te bi se odredbe trebale primjenjivati ne dovodeći u pitanje pravo Komisije da podnosi zahtjeve Europskoj agenciji za sigurnost hrane (EFSA) za davanje znanstvenih mišljenja u skladu s člankom 29. i pružanje znanstvene ili tehničke pomoći u skladu s člankom 31.
Such data are essential in order to perform the commodity risk assessment and to identify the pest species for which phytosanitary mitigation measures may be required.
Uredbe (EZ) br. 178/2002 Europskog parlamenta i Vijeća.
In order to provide EFSA with all the necessary elements to conduct the risk assessment, the technical dossier should contain the information specified in the EFSA document entitled ‘Information required for dossiers to support demands for import of high risk plants, plant products and other objects as foreseen in Article 42 of Regulation (EU) 2016/2031’.
Tehnička dokumentacija trebala bi sadržavati podatke o robi koja se unosi na područje Unije te podatke o identifikaciji štetnih organizama koji su potencijalno povezani s tom robom u zemlji izvoznici, podatke o nacionalnim fitosanitarnim mjerama za smanjenje rizika, inspekcijama te postupcima tretiranja i preradi robe te podatke za kontakt fizičke osobe nadležne za kontakt s Komisijom i EFSA-om.