Notification Detail

Royal Decree on metal and alloy materials and articles intended to come into contact with food

Notification Number: 2018/442/B (Belgium)
Date received: 05/09/2018
End of Standstill: 06/12/2018

Issue of comments by: Austria,Commission,Greece,Spain
bg cs da de el en es et fi fr hr hu it lt lv mt nl pl pt ro sk sl sv
bg cs da de el en es et fi fr hr hu it lt lv mt nl pl pt ro sk sl sv


Message 002

Communication from the Commission - TRIS/(2018) 02399
Directive (EU) 2015/1535
Translation of the message 001
Notification: 2018/0442/B

No abre el plazo - Nezahajuje odklady - Fristerne indledes ikke - Kein Fristbeginn - Viivituste perioodi ei avata - Καμμία έναρξη προθεσμίας - Does not open the delays - N'ouvre pas de délais - Non fa decorrere la mora - Neietekmē atlikšanu - Atidėjimai nepradedami - Nem nyitja meg a késéseket - Ma’ jiftaħx il-perijodi ta’ dawmien - Geen termijnbegin - Nie otwiera opóźnień - Não inicia o prazo - Neotvorí oneskorenia - Ne uvaja zamud - Määräaika ei ala tästä - Inleder ingen frist - Не се предвижда период на прекъсване - Nu deschide perioadele de stagnare - Nu deschide perioadele de stagnare.

(MSG: 201802399.EN)

1. Structured Information Line
MSG 002 IND 2018 0442 B EN 05-09-2018 B NOTIF


2. Member State
B


3. Department Responsible
FOD Economie, KMO, Middenstand en Energie
Algemene Directie Kwaliteit en Veiligheid - Dienst Normalisatie en Competitiviteit - BELNotif
NG III – 5de verdieping
Koning Albert II-laan, 16
B - 1000 Brussel
Tel: 02/277.93.71


3. Originating Department
Federale Overheidsdienst Volksgezondheid, Veiligheid Voedselketen en Leefmilieu
Directoraat-generaal Dier, Plant en Voeding
Dienst Voedingsmiddelen, Dierenvoeders en Andere Consumptieproducten
Eurostation, Victor Hortaplein 40/10, 1060 Sint-Gillis, België
tel.: 02 524 73 63
els.heyvaert@health.belgium.be


4. Notification Number
2018/0442/B - C00A


5. Title
Royal Decree on metal and alloy materials and articles intended to come into contact with food


6. Products Concerned
Materials and articles intended to come into contact with food


7. Notification Under Another Act
- Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC


8. Main Content
The purpose of this draft royal decree is to regulate materials made of metals and alloys which are intended to come into contact with food. The present text lays down specific release limits for metals as well as the information to be included in declarations of conformity.
The text is based on Council of Europe Resolution CM/Res(2013)9 on metals and alloys used in food contact materials and articles.


9. Brief Statement of Grounds
The lack of specific European legislation on metal and alloy materials and articles intended to come into contact with food poses a serious problem of uncertainty for both governments and industry. Article 3 of Regulation 1935/2004 is insufficient for ensuring a high level of consumer health protection. It was therefore decided to prepare a draft national regulation integrating the principle of mutual recognition so that industry can unambiguously ensure that products comply with the legislation.
This legislation ensures a higher degree of consumer health protection by laying down specific release limits for metals and alloys in contact with food, as well as specific release limits for metal pollutants and impurities in the aforementioned metals and alloys.


10. Reference Documents - Basic Texts
Numbers or titles of the basic texts: Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC


11. Invocation of the Emergency Procedure
No


12. Grounds for the Emergency
-


13. Confidentiality
No


14. Fiscal measures
No


15. Impact assessment
-


16. TBT and SPS aspects
TBT aspect

No - the draft has no significant impact on international trade.

SPS aspect

No - the draft has no significant impact on international trade.



**********
Europese Commissie

Contactpunt Richtlijn (EU) 2015/1535
Fax: +32 229 98043
email: grow-dir2015-1535-central@ec.europa.eu

Stakeholders Contributions

The TRIS website makes it easy for you or your organization to contribute with your opinion on any given notification.
Due to the end of standstill we are currently not accepting any further contributions for this notification via the website.


en
  Metal Packaging Europe on 05-12-2018
Click to expand

 

Belgian Draft Decree (RD) on Metals and Alloys – response from Metal Packaging Europe to the TRIS notification

 

5 December 2018

 

SUMMARY

 

The draft RD is not the most appropriate or realistic way to control consumer exposure to metals and alloys in foods. Not only would it fail to properly protect consumers, it would:

 

·         introduce significant complexity and cost to the supply chain for canned/jarred food and beverage

 

·         it would lead to significant workload for control authorities without any commensurate improvement in consumer protection

 

·         it would lead to a distortion in the market as the, at best, partial implementation of control measures would be applicable disproportionately to industry in and around Belgium

 

An acceptable means to control consumer exposure to metals in foods already exists in the Contaminants Regulation without the flaws and disadvantages that are inevitably introduced by the approach used in the draft RD

 

INTRODUCTION

 

Until now, with the exception of the Council of Europe (CoE) Resolution CM/Res (2013)9,  the safety of metals and alloys intended to come into contact with food has been controlled nationally and internationally by a combination of standards (ISO / CEN / national standards) limiting the concentration of toxic elements in the metallic materials and legal requirements limiting the concentration of toxic elements (contaminants) in food. This system has been widely demonstrated to provide adequate consumer protection and allows easy and efficient control measures on all levels of the value chain.  In contrast, the draft Belgian RD follows the concept of specific release limits (SRL) for metals which was introduced by CoE for the first time. So far, this concept has not proven to be workable because the release of metal ions from metals and alloys into food is a complex chemical process which in most cases cannot be simulated under laboratory conditions. Furthermore, this concept is not compatible with the EU regulations on contaminants in food (Regulation (EC) No. 1881/2006) which regulates the maximum level of certain metals in food regardless of where the metal originates from. There is no reasoning in the draft RD or associated documents why there should be a deviation away from the established and internationally recognised principles, moving instead to an attempt to control consumer exposure to metals from just one of several potential sources, introducing many practical limitations which the existing control measures do not have without any obvious increase in consumer protection.

 

DETAILED COMMENTS

 

1.       According to Art. 1 of the draft Belgian RD, not only plain (uncoated), but also internally coated metallic materials and articles would be in the scope of the decree. For metal packaging this would result in the need for excessive compliance testing for each type of metal packaging, regardless of whether it is plain or coated using as yet non-existent validated methods. Currently, internally coated cans are not routinely tested for the release of metal ions into food because under intended and foreseeable conditions of use

 

 

 

 

 

 

 

 

 

2.       there is no relevant release of metal ions into food. Any significant release of metal into food from internally coated metal packaging would be an indication of failure of the internal protection system which would be picked up during the package evaluation process before commercialisation.

 

3.       Art. 5 § 1 of the draft RD requires release tests in order to demonstrate conformity of metallic materials and articles. The tests must be carried out with “known national and European test methods”. It remains unclear what these test methods are. In fact, apart from the test procedures described in the CoE practical guide “Metals and alloys used in food contact materials and articles” there are no procedures described for release testing of metal ions from metallic food contact materials. The test methods described in the CoE practical guide are not validated and do not follow recognised standards. First practical experiences with the test procedures described in the CoE practical guide show major problems, not only regarding repeatability of the procedures, but also with regard to significance of the test results obtained after use of food simulants if they are compared to the real situation under food contact conditions. Furthermore, in particular for metal packaging the test methods using food simulants are inappropriate because they do not reflect the complex conditions of release of metal ions into food in hermetically sealed containers (absence of oxygen, buffering and passivating effect of natural food ingredients, etc). A clear exemption from release testing with food simulants for metal packaging that is intended to be hermetically sealed under commercial conditions is needed.  Industry would be happy to give clear and simple guidance allowing the easy identification of metal packaging that is or is intended to be hermetically sealed. 

 

4.       It also remains unclear what the scope of the release tests should be. It appears that in order to demonstrate conformity of a material or article a release test for each element for which the RD sets an SRL must be carried out. This will require testing for 23 elements regardless of which type of metallic material or article is tested resulting in significant extra costs for industry without any increase in consumer protection – the only beneficiary will be the test laboratories. For most elements there will be a “non-detectable” result because these elements are simply not present in the metal or alloy.

 

5.       There is no reference in the draft Belgian RD to a guidance document on test methods which was announced by the Belgian Ministry of Health. Without a clear reference to appropriate methods for release testing the draft Belgian RD remains unacceptable for industry because it will install requirements for which compliance cannot be demonstrated.

 

6.       The concept of SRLs does not allow the public enforcement of the law by testing of filled metal packaging drawn from the shelves of retailers because the natural concentration of metal ions in the food before packing is unknown and therefore the release of the ions from the packaging material into food cannot be calculated.

 

7.       The concept of SRLs is not directly relevant to consumer protection because it is the total amount of any particular metal that is consumed in the food that controls consumer exposure and so it should be the total level in food from whatever source that is used for consumer protection through extension of the Contaminants Regulation which already controls many key metals.   

 

8.       Attempts to enforce the law through testing of empty metal packaging using real foods or beverages packed under commercial conditions would disadvantage Belgian fillers as it would not be realistically possible to do that such work for imported canned foods or beverages