Customs blockade of xanthan gum for ethylene oxide?

Dear Dario good morning,

our company imported a small amount of xanthan gum from China, 4 tonnes, with exact knowledge of a minimal level of ethylene oxide contamination which we know is systemic in many Asian products.

In application of the IFS certified food safety management procedures, as well as in a logic of transparent interaction with the customs authorities, the analyzes on ethylene oxide were attached to the import documents.

The Customs of Genoa, however, blocked the import first because, according to them, there was no phytosanitary certificate issued by the manufacturer before departure, then due to the presence of EPO documented by ourselves.

Following notification of a provision prohibiting entry into the EC of the product in question and obligation to return it to the supplier or to destroy it, we have requested a priori the downgrading of the product for industrial technical use, without however receiving feedback.

How do you recommend getting around? Many thanks as always, Ugo


The lawyer Dario Dongo, Ph.D. in European food law, answers

Dear Ugo good morning,

the phytosanitary certificate is completely out of place in the case of xanthan (or xanthan gum, xhantan gum) since it derives from the enzymatic fermentation process of a bacterium (Xanthomonas campestris) and not from a plant (1,2).

1) Introduction. Xanthan gum

Xanthan gum it is the most widespread microbial polysaccharide on a planetary level. Discovered in the 50s by Allene Rosalind Jeanes at USDA (U.S. Department of Agriculture), was approved by the FDA (Food and Drug Administration) in 1969 as a non-toxic and safe polymer.

Industrial production of xanthan began as early as the early 60s by the Kelco Company, now CP Kelco. The first player industrialists in Europe were Jungbunzlauer Austria AG and Solvay, which marketed xanthan gum Rhodopol brand. Since 2005, China has become the leader market. (3)

2) Xanthan, uses

Xanthan is an extremely versatile polysaccharide of microbial origin. It is used both as a food additive - E 415, subject to re-evaluation by EFSA (2017) which confirmed its safety of use also in baby food, from 4 months of consumer life (4) - and in a wide range of variety of industrial sectors.

Xanthan gum has numerous industrial applications in the cosmetic and personal hygiene sectors (e.g. creams, lotions, toothpastes, shampoos), biomedical and pharmaceutical, chemical, .. (5,6). Its ability to give consistency to water is also exploited by the oil industry, in drilling fluids that must agglomerate and carry mud and residues. (7)

3) Customs, unjustified blocking

Due to the above, the customs block on a consignment of xanthan gum (xanthan gum) as it contains traces of ethylene oxide, it cannot be justified where the importer indicates its destination for uses other than food.

The circumstance that the importer - moreover subject to a procedure of food safety management certified - has attached to the import documents the certificate of analysis relating to ethylene oxide is among other things in itself emblematic of its good faith.

4) Administrative measure

It is not possible to evaluate the legitimacy of an administrative measure without reading its content which, on the basis of the few information available, could present vices of legitimacy. With particular regard to the motivation which is the central part of the provision and must:

  • indicate both the factual assumptions and the legal reasons for the decision of the public administration in relation to one or more subjects,
  • include an investigation, in the provision itself or in a previous deed to which an express reference is made. This investigation, in the specific case, must also consider the declarations of the importer regarding the destination of the goods. (8)

5) Cases of invalidity and annulment, liability

The defects of the provision administrative, it is worth remembering, can have several consequences

5.1) Nullity of the deed

The nullity of the act it can be declared ex officio or at the request of the appellant, in any state and grade of the trial. It exists in cases where the sanctioning measure:

  • has been issued by an Authority lacking the competence to adopt it (as it is not expressly attributed powers by law), (9)
  • does not correctly identify the recipient and / or recipients of the sanction,
  • is undated,
  • is completely lacking in motivation,
  • omits the time limits within which it can appeal,
  • fails to indicate the competent authority to evaluate any appeal,
  • is contested by irregular means of notification,
  • is notified to the recipient after 90 days from the date of the finding of the violation. (9)

5.2) Annulment of the administrative measure

The annulment of the administrative measure is instead linked to minor defects, such as:

  • has been adopted by omitting, or by applying incorrectly, the applicable rules (violation of the law),
  • adoption of the act by an office other than the one formally charged with imposing the sanction, within the competent Authority (relative incompetence),
  • unreasonable or unsuitable motivation to justify the imposition of a specific sanction or a certain proportion of the same (excess of power). (10)

5.3) Responsibility in case of delay

Delay of the public administration in responding to the requests of the administrated, it should also be emphasized, may also involve the criminal responsibility of the officials in charge.

Omission of official documents. ‘A public official or person in charge of a public service, who improperly refuses an act of his office which, for reasons of justice or public safety, or public order or hygiene and health, must be carried out without delay, is punished with imprisonment from six months to two years.

Out of the foreseen cases from the first paragraph, the public official or the person in charge of a public service, who within thirty days of the request of those who have an interest does not perform the act of his office and does not respond to explain the reasons for the delay, is punished with imprisonment up to one year or with a fine of up to € 1.032. This request must be drawn up in writing and the term of thirty days starts from the receipt of the request. ' (11)

6) Ethylene oxide, the unresolved crisis

The 'ethylene oxide' phenomenon was the protagonist of the largest number of alert notifications on the Rapid Alert System for Food and Feed (RASFF) from 2019 to today, as we have seen. (12) And the European Commission has handled this food security crisis with extraordinary ambiguity, given that:

  • on the assumption of the carcinogenic nature of ethylene oxide, the Member States have ordered the recall of any food product that could contain it even in quantities lower than Level of Detection (LoD),
  • the DG Sante of the European Commission, despite the numerous notifications to the RASFF for the presence of the contaminant in agricultural and foodstuffs arriving from India, already starting from September 2020, (13) delayed the prescription of the reinforced controls on these matrices at the EU borders, arranged only in December 2021 with reg. EU 2021/2246,
  • the European Commission also failed to ask EFSA for a risk assessment on foods that may contain ethylene oxide in undetectable quantities. (14)

6.1) Levels of exposure out of control

EPA (Environment Protection Agency, USA) estimates that roughly 50% of sterile medical devices - including face masks widely used every day for the past 2 years, by much of the global population, are worth adding - are treated with ethylene oxide. Specifying that this substance 'it is also used to sterilize some food products such as spices, some dried herbs, dried vegetables, sesame seeds and nuts'. As well as in the production of antifreeze, plastics, detergents and adhesives. (15) A scientific assessment of exposure levels from various sources is therefore essential, on the basis of which consistent decisions can be made.

7) EU Reg. 2022/1396, new tolerance threshold for ethylene oxide in food additives

The reg. EU 2022/1396 of the Commission, in force since 1.9.22, amends the annex to reg. EU 231/2012 which establishes the specifications of food additives referred to in Annexes II and III of reg. CE 1333/08 'as regards the presence of ethylene oxide in food additives:

1) the introductory text 'Note: ethylene oxide cannot be used for sterilization in food additives' is replaced by the following:
'The use of ethylene oxide in food additives for sterilization purposes is not permitted.
The presence of ethylene oxide residues (sum of ethylene oxide and 2-chloro-ethanol, expressed as ethylene oxide [16]) exceeding 0,1 mg / kg, regardless of their origin, in food additives is not allowed listed in Annexes II and III of Regulation (EC) No. 1333/2008, including mixtures of food additives.

2) the entries relating to E 431 polyoxyethylene stearate (40), E 432 polyoxyethylene sorbitan monolaurate (polysorbate 20), E 433 polyoxyethylene sorbitan monoleate (polysorbate 80), E 434 polyoxyethylene sorbitan monopalmitate (polysorbate 40), E 435 polyoxyethylene sorbitan monostearate (polysorbate 60), E 436 polyoxyethylene sorbitan tristearate (polysorbate 65), E 1209 graft copolymer of polyvinyl alcohol-polyethylene glycol and E 1521 polyethylene glycol, in the specification "Purity" the line "Ethylene oxide" is deleted. ' (EU Reg. 2022/1396)

8) Provisional conclusions

The Italian Customs - whose officials, like the many others of the various administrations responsible for official controls, unfortunately do not receive adequate training on food law - can neither afford to block nor to delay the release of goods legitimately imported into the EU. In fact, operators can:

  • protect their rights in the competent administrative and judicial offices, also for the compensation of unjust damages linked to the (often exorbitant) costs of storing goods blocked in customs warehouses. With unnecessary outlays for the Treasury and personal risks of convictions of individual officials,
  • decide to import goods through other ports where these situations do not occur or are at least rare, such as in Rotterdam. Understandable choices that nevertheless harm the country-system due to the loss of both import duties and the economy and employment linked to import, storage and logistics. Such a pity.

cordially

Dario

Cover image from Xanthan Gum Market Analysis 2022-2028. Consistent market insights.

Notes

(1) Namita Jindal and Jasvirinder Singh Khattar (2018). Microbial Polysaccharides in the food industry. Chapter 4 of the book Biopolymers for Food Design. Elsevier. ISBN 978-0-12-811449-0. doi: https://doi.org/10.1016/C2016-0-00686-1

(2) The import of guar gum (locust bean gum), with which the xanthan gum it is often confused, it is instead subject to a health certificate as it derives from the seeds of the plant

(3) Tao F, Wang X, Ma C, Yang C, Tang H, Gai Z, Xu P. (2012). Genome sequence of Xanthomonas campestris JX, an industrially productive strain for Xanthan gum. J Bacteriol. 2012 Sep; 194 (17): 4755-6. doi: 10.1128 / JB.00965-12. Erratum in: J Bacteriol. 2012 Nov; 194 (22): 6367

(4) Re-evaluation of xanthan gum (E 415) as a food additive (2017). EFSA Journal 2017; 15 (7): 4909. doi: https://doi.org/10.2903/j.efsa.2017.4909

(5) Barel, AO; Maibach, HI (2001). Handbook of Cosmetic Science and Technology. CRC Press, Boca Raton. ISBN 9780429164521.doi: https://doi.org/10.1201/9780824741396

(6) Denise FS Petri (2015). Xanthan gum: A versatile biopolymer for biomedical and technological applications. J. Appl. Polym. Ski., 132, 42035, doi: 10.1002 / app. 42035

(7) Denise FS Petri, João C. de Queiroz Neto (2010). Identification of lift-off mechanism failure for salt drill-in drilling fluid containing polymer filter cake through adsorption / desorption studies. JJournal of Petroleum Science and Engineering, Volume 70, Issues 1–2, 2010, Pages 89-98.
https://doi.org/10.1016/j.petrol.2009.10.002

(8) See article 3 of law 7.8.1990 n. 241, New rules on administrative procedure and right of access to administrative documents. Text updated on 30.7.21 on Normativehttps://bit.ly/3PSHQNx

(9) An example of a null act due to an absolute lack of attribution is the provision of a customs authority that censors the information to the consumer (eg labels) of food products. The exclusive competence in this area is indeed entrusted to ICQRF (Legislative Decree 231/17). V. Dario Dongo. It is legitimate to import packaged food without labels, clarifies ICQRF. FARE (Food and Agriculture Requirements). 1.4.22

(9) Law 241/90, article 21‒f (whose paragraph 2 was repealed with Legislative Decree 2.7.10 n. 104)

(10) Law 241/90, article 21‒octies (introduced by law 11.2.05 n. 15, art. 14. Paragraph 2 of article 21‒octies it was most recently reformed with Legislative Decree 16.7.20 n. 76, art. 12.1.d

(11) Criminal Code, article 328

(12) Dario Dongo. Ethylene oxide, recalls in the EU without reinforced border controls. GIFT (Great Italian Food Trade). 23.9.21

(13) Dario Dongo. Ethylene oxide, Indian night and Cypriot sunset. GIFT (Great Italian Food Trade). 6.11.21

(14) Take the example of a xanthan gum (xanthan gum) which contains traces of in the amount 0,01% (= 0,1 g / kg). Since xanthan gum is used in 0,1% share in food products, the concentration of ethylene oxide in the final food is equal to 0,1 ppm (= 100 ppb = 0,1 mg / kg), which coincides with the LoD of many analysis protocols

(15) Frequent Questions about Ethylene Oxide (EtO). https://www.epa.gov/hazardous-air-pollutants-ethylene-oxide/frequent-questions-about-ethylene-oxide-eto EPA (Environmental Protection Agency, USA). 3.8.22

(16) 'ie ethylene oxide + 0,55 * 2-chloro-ethanol ''.



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