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1. ------IND- 2020 0510 D -- EN- ------ 20200830 --- --- PROJET 
 
Draft of the Federal Ministry of Food and Agriculture  
Twenty -Second Ordinance amending the Consumer Goods 
Ordinance1)  
of…2020  
The Federal Ministry of Food and Agriculture decrees the following on the basis of  
˗ § 31(2)(1)(2), also in conjunction with § 4(2)(2), and § 46(2)(1)(1)(a) of the Food 
and Feed Code as promulgated on 3 June 2013 (Federal Law Gazette I p. 1426) and  
˗ § 34(1)(2), as amended by Article  67(6) of the Ordinance of 31 August 2015 
(Federal Law Gazette I p. 1474), also in conjunction with § 4(2)(2) of the Food and Feed 
Code as promulgated on 3 June 2013 (Federal Law Gazette I, p. 1426), in consultation 
with th e Federal Ministry for Economic Affairs and Energy:  
Article  1 
Amendment to the Consumer Goods Ordinance  
The Consumer Goods Ordinance, as published on 23 December 1997 (Federal Law 
Gazette 1998 I p.  5), last amended by Article  2(1) of the Act of 15 February  2016 (Federal 
Law Gazette I p.  198), is amended as follows:  
1. § 2 is amended as follows:  
a) In point  6, the full stop at the end is replaced by a semicolon.  
b) The following points  7 to 10 are added:  
‘7. Waste paper pulp: fibre material obtained from waste paper through 
processing methods for the manufacture of paper, paperboard or cardboard;  
8. Aromatic mineral oil hydrocarbons: alkylated aromatic hydrocarbons with 
carbon numbers C16 to C35 which contain one or more rings, with the exception 
of diisopropylnaphthalenes; the carbon numbers are linked to the elution ranges 
or to the retention times of the corresponding n -alkanes in the gas 
chromatographic analysis on a dimethylpolysiloxane -coated separation column;  
9. Functional barriers:  
a) one or more layers or coatings of a food contact material or  
b) the wrapping of a foodstuff,  
                                                
1) Notified in accordance with Directive  (EU) 2015/1535 of the European Parliament and of the Council 
of 9 September 2015 laying down a procedure for the provision of information in the field of technical 
regulations and of rules on Information Society servic es (OJ  L 241, 17.9.2015, p.  1).  - 2 - As at: 14/08/2020 Time:  15:07 
which ensures that certain substances from food contact materials do not migrate 
to the food;  
10. Food simulant:Food simulant as defined by Article 3(12) of Regulation 
(EU) No  10/2011.’  
2. The following §  6a is inserted after §  6: 
‘§ 6a 
Food contact materials made of paper, paperboard or cardboard with a proportion of 
recycled paper  
(1) Food contact materials made of paper, paperboard or cardboard using recycled 
paper may onl y be manufactured and placed on the market if a functional barrier in 
accordance with § 2(9) ensures that no aromatic mineral oil hydrocarbons are 
transferred from the food contact materials to the food. A transfer is deemed not to 
have occurred if  
1. the  detection limit of 0.5 milligrams of the sum of aromatic mineral oil hydrocarbons 
per kilogram of food is not exceeded or  
2. the detection limit of 0.15 milligrams of the sum of aromatic mineral oil 
hydrocarbons per kilogram of food simulant is not excee ded.  
(2) P aragraph 1(1) does not apply if a transfer of aromatic mineral oil 
hydrocarbons from the food contact material to food as defined by paragraph 1(2) is 
precluded because  
1. there are special requirements for the food contact material, in particul ar that there 
is only a low content of aromatic mineral oil hydrocarbons in the food contact article, 
or 
2. the manufacturer or distributor of the food contact material has taken other suitable 
measures to prevent a transfer.  
(3) In deviation from paragrap h 1(1), the food contact materials described there 
can be manufactured and placed on the market without a functional barrier if the food 
business operator who brings the food contact material into contact with a food for the 
first time by packaging or in a ny other way, declares to the manufacturer or distributor 
of the food contact material in writing or electronically before delivery of the food 
contact material that he will dispense with the functional barrier pursuant to § 2(9).  
(4) In the cases of para graph 3, the food business operator using the food contact 
material must ensure that a transfer of aromatic mineral oil hydrocarbons from the 
food contact material to food as defined by paragraph 1(2) is precluded. For this 
purpose, he must use a functiona l barrier according to § 2(9)(b) or take other suitable 
measures. Sentence 2 does not apply if special requirements exist that prevent 
aromatic mineral oil hydrocarbons from migrating from the food contact material to the 
food as defined by paragraph 1(2),  in particular due to the nature of the food that 
comes into contact with the food contact material, or due to the intended conditions of 
use of the food contact material.  
(5) At the request of the competent authority, the following must be presented:  
1. The compliance of the manufacturer or distributor of the food contact material with 
the requirements of paragraphs 2 and 3 and   - 3 - As at: 14/08/2020 Time:  15:07 
2. The compliance of the food business operator with the requirements of paragraph 
4. 
The persons with an obligation under senten ce 1 must keep documents that prove 
that a transfer of aromatic mineral oil hydrocarbons from the food contact material to 
food or food simulants as defined by paragraph 1(2) is precluded.  
(6) It is forbidden to place foodstuffs on the market as foodstuffs  which have been 
handled using a food contact article without the requirements of paragraph 1(1) or 
paragraph 4(1) being met.’  
3. In § 7(1), ‘6’ is replaced by ‘6a(4)’.  
4. § 12 is amended as follows:  
a) Paragraph  2 is amended as follows:  
aa) In point 3, the word ‘or’ is replaced by a comma.  
bb) In point  4, the full stop at the end is replaced by a comma.  
cc) The following points  5 and 6 are added:  
‘5. contrary to § 6a(1)(1) or paragraph 6, places a food contact or foodstuff 
on the market or  
6. contrary to § 6a( 4)(1), does not ensure that a transfer of aromatic mineral 
oil hydrocarbons is precluded.’  
b) Paragraph  6 is amended as follows:  
aa) The following point 1 is placed before point 1:  
‘1. contrary  to § 6a(5)(2), fails to keep documentation, or fails to do so 
correctly or in full.’  
bb) The previous point  1 becomes point 2.  
5. The following paragraphs 15 and  16 are added to § 16:  
‘(15) § 6a only applies from ... [insert: date of the first day of the thirty -seventh 
month following the calendar month of publication of this Ordinance].  
(16) Food contact materials that have been manufactured using recycled paper in 
accordance with the regulations applicable up to the point in time specified in 
paragraph 15 may s till be placed on the market and used until ... [: date of the first 
day of the sixty -first calendar month following the promulgation of this Ordinance].’  
Article  2 
Promulgation authorisation  
The Federal Ministry of Food and Agriculture can publish the wor ding of the 
Consumer Goods Ordinance in the current version of ... [Insert: date of entry into force of 
this Ordinance] in the Federal Law Gazette.   - 4 - As at: 14/08/2020 Time:  15:07 
Article  3 
Entry into force  
This Ordinance shall enter into force on the day following its promulgation.  
Approved by the Bundesrat.  
Bonn, on .....2020  
 
T h e  F e d e r a l  M i n i s t e r   
f o r  F o o d  a n d  A g r i c u l t u r e   - 5 - As at: 14/08/2020 Time:  15:07 
Explanatory statement  
A. General part  
I. Objective of and need for the regulations  
Food can be contaminated with mineral oil, as has been shown inter alia by studies  within 
the framework of a research project funded by the Federal Ministry of Food and 
Agriculture (extent of migration of undesirable substances from packaging materials from 
waste paper to food - extra report on the analysis of ‘119 foods’ for undesirabl e 
substances from waste paper, funding code 2809HS012). In addition to other sources of 
entry, food packaging made of paper, paperboard or cardboard, especially when made of 
recycled paper, is a major cause.  
Mineral oil can enter the recycled paper throug h the recovery of waste paper. Recycled 
paper contains fibre that is obtained from waste paper (known as waste paper material). 
Waste paper mainly consists of newspapers, advertising leaflets, magazines, catalogues 
and other graphic paper materials as well  as packaging paper. To print on these papers, 
printing inks are used which, depending on the printing process and area of application, 
also contain mineral oil.  
Mineral oil is obtained from petroleum and is a complex mixture, which mainly consists of 
saturated (chain and ring -shaped) and aromatic (mostly alkylated) hydrocarbons. 
Considerable amounts of mineral oil hydrocarbons were found in food in some cases. 
These also include aromatic mineral oil hydrocarbons (MOAH). In the opinion of the 
Federal Instit ute for Risk Assessment (BfR), the inclusion of MOAH should be minimised 
(e.g. BfR Opinion No. 008/2010, BfR Press Information 41/2012, BfR FAQ of 30 
November 2012/26 November 2015), because it cannot be ruled out that the MOAH 
contain substances that caus e harm to the health, such as cancer. The European Food 
Safety Authority (EFSA) also raised concerns in its opinion of 3 May 2012 (EFSA Journal 
2012;10 (6):2704) with regard to exposure to MOAH due to its possible carcinogenic 
potential. The EFSA also foun d that food packaging based on waste paper stock can 
make a significant contribution to mineral oil hydrocarbon exposure from food.  
This Ordinance is intended to significantly improve the protection of consumers against 
possible health hazards caused by fo od contact materials made of paper, paperboard or 
cardboard, which are manufactured using recycled paper and from which MOAH can be 
transferred to food.  
II. Main content  
The purpose of this Ordinance is to limit the migration of MOAH to foodstuffs from food 
contact materials made of paper, paperboard or cardboard which are manufactured using 
recycled paper stock to the greatest extent possible. A suitable means of introducing such 
a limitation is a functional barrier. A basic obligation is therefore established  to equip the 
relevant food contact materials with such a functional barrier. According to this Ordinance, 
the functionality of the barrier is determined by a detection limit of 0.5 milligrams MOAH 
per kilogram of food for the transfer from the food contac t material. When testing in food 
simulants, a detection limit of 0.15 milligrams MOAH per kilogram of food simulant 
applies. However, the obligation of the manufacturer or distributor of food contact 
materials to equip the food contact materials with a fun ctional barrier does not apply if the 
food business operator who procures the food contact material declares to the 
manufacturer or distributor that it does not require a functional barrier before delivery. In  - 6 - As at: 14/08/2020 Time:  15:07 
this case, the food business operator must tak e its own measures to ensure that a transfer 
from MOAH to food does not take place, unless there are special conditions, e.g. with 
regard to the nature of the food, which prevent the transfer of MOAH to food. The 
obligation to equip the food contact materi als with a functional barrier also does not apply 
if the manufacturer or the distributor of the food contact materials can guarantee in a way 
other than the use of a functional barrier that a transfer from MOAH to food is precluded. 
This can for example be  the case if the MOAH content in the paper, paperboard or 
cardboard itself is so low that there is no transfer from MOAH to food above the detection 
limit. 
III. Alternatives  
None. In order to protect the health of consumers and to ensure uniform handling, 
appro priate legal requirements and the mandatory application of a detection limit for 
MOAH in food are required.  
IV. Legislative powers  
The Federal Ministry of Food and Agriculture is empowered to enact this Ordinance by § 
31(2)(1)(2) LFGB (Food and Feed Code), al so in conjunction with § 4(2)(2) and § 
46(2)(1)(1)(a) LFGB, as well as § 34(1)(2), also in conjunction with § 4(2)(2) LFGB.  
V. Compatibility with European Union law and international treaties  
The EU law on food contact materials has not yet been fully harmoni sed. Regulation (EC) 
No. 1935/2004 does provide general requirements. However, individual measures have 
so far only existed for individual material groups. Article 6 of Regulation (EC) No. 
1935/2004 allows the EU member states to maintain or enact national  provisions for 
groups of materials and objects for which no individual measures have yet been taken at 
EU level. There are no such individual EU measures for food contact materials made of 
paper, cardboard or cardboard – be it either from fresh fibre or f rom waste paper. 
Consequently, it is compatible with EU law. International treaties are not affected.  
VI. Legal consequences  
1. Legal and administrative simplification  
This Ordinance does not provide for a simplification or repeal of provisions. However, the 
requirements with regard to the avoidance of a transfer of MOAH from food contact 
materials made of paper, paperboard or cardboard containing recycled paper will be 
standardised, thereby significantly improving legal certainty for both the competent 
authorities of the federal states and the businesses concerned.  
2. Sustainability aspects  
A sustainability review has been carried out in accordance with the fourth sentence  of 
Section  44(1) of the Joint Rules of Procedure of the Federal Ministries (GGO). The 
provisions are permanently sustainable within the meaning of the national sustainability 
strategy. The global sustainability goal 3 is of particular relevance. ‘To ensur e a healthy 
life for people of all ages and promote their well -being’. Furthermore, the principle of 
sustainable development point 3) b) ‘Prevent dangers and unacceptable risks to human 
health’ is taken into account. It also contributes to global goal 12 ‘ Ensure sustainable 
consumption and production patterns’. In the interests of sustainability, the use of 
recycling materials for food contact materials made of paper, paperboard or cardboard will  - 7 - As at: 14/08/2020 Time:  15:07 
also be possible in the future, provided that the consumer pr otection requirements 
specified in this Ordinance are met. The Ordinance ensures that consumers are not 
adversely affected by mineral oil components from food contact materials made of paper, 
paperboard or cardboard that have been produced using recycled p aper. The Ordinance 
serves the purpose of consumer health protection, contributing to sustainable 
development.  
3. Budgetary expenditure exclusive of compliance costs  
State budgets are not burdened with public expenditure beyond compliance costs.  
4. Compliance c osts 
a) Administrative compliance costs  
The Ordinance does not incur any additional costs for the federal administration.  
Based on the information provided by the states, the administration of the states incurs 
the following additional compliance costs du e to additional monitoring and control 
activities through the Ordinance:  
One-off material costs:  approx. EUR 1 058 000  
One-off personnel costs:  approx. EUR 123  000 
Annual material costs  approx. EUR 80  000 
Annual staff costs  approx. EUR 292  000 
This results in an average one -time compliance cost of EUR 236 200 and an average 
annual compliance cost of EUR 74 400.  
These costs are made up of the following items in accordance with the individual details 
below jointly provided by the states. Not all states reported a cost impact from the 
Ordinance. This could, for instance, be due to the fact that such investigations are initially 
not carried out or that they are carried out in cooperation with other states.  
Baden -Württemberg:  
 
One-off material costs : EUR 220 000 (equipment procurement)  
One-off personnel costs:  EUR 35 000 (establishment of 
standardised analysis without measuring 
routine samples)  
Annual material costs:  approx. EUR 10 000 (estimate) (device 
maintenance, consumables, repairs, etc.)  
Annual staff costs:  approx. EUR 60 000 (assuming that a CTA 
and a laboratory manager are each 
deployed 50%; the actual annual personnel 
costs are dependent on the actual number 
of samples and the actual costs for the 
document review).  
 
The specified costs  include the costs for the analysis and the costs for only part of the 
document review in the testing facility, since there is no obligation to register companies in 
the area of the production and placing on the market of food contact materials and  - 8 - As at: 14/08/2020 Time:  15:07 
therefo re no complete data on the number of those manufacturers and distributors of the 
food contact materials covered by the Ordinance.  
 
Bavaria:  
 
One-off material costs:  approx. EUR 200  000  
Annual staff costs:  approx. EUR 72  000  
Annual material costs:  approx. EUR 10  000  
 
Lower Saxony:  
 
One-off material costs:   Approx. EUR 1700 00 (device costs for 
HPLC -GC coupling)  
 
Annual costs:  EUR 52,000 (based on 200 samples to be 
examined and 40 document reviews per 
year ) 
 
Schleswig -Holstein  
 
One-off material costs:  EUR 238 000 (device costs for LC -GC 
coupling; device was purchased in March / 
April 2017)  
One-off personnel costs:  EUR 5 000 (training)  
Annual staff costs:  approx. EUR 70 000 (0.5 positions for 
scientific staff E14  
1 position technical employee E9) 
 
Saxony:  
 
One-off material costs:  EUR 230 000 (equipment procurement)  
 
One-off personnel costs:  EUR 83 000 (0.5 FTE salary group 13+ 
and 1.0 FTE salary group 6 in the phase of 
familiarisation with the analysis equipment 
concerned and for the application of the 
method)  
 
Annual material costs:  approx. EUR 6 000 to 8 000 EUR 
(equipment maintenance, consumables, 
repairs)  
Annual staff costs:  approx. EUR 90 000 (2.0 FTE pay group 6 
in routine operation)  
 
Saxony -Anhalt  has not yet been able to quantify the one -off and recurring costs.   - 9 - As at: 14/08/2020 Time:  15:07 
  
Thuringia  announced that not inconsiderable one -off costs are likely. A detailed 
specification of costs is not feasible for Thuringia at this stage.  
 
b) Implementation costs for the trade and industry  
With respect to compliance costs for trade and industry, the Ordinance results in 
additional costs in particular for medium -sized companies. Since the problem of the 
contamination of food with mineral oil components from food commodities has been 
known for a lo ng time, a number of type of packaging have already been converted by 
e.g. intermediate bags, coatings or virgin fibres used instead of fibres based on recycled 
paper. However, changes will now also be required for a significant further proportion of 
food contact materials, unless the planned exception applies.  
An ex -ante estimate by the Federal Statistical Office resulted in one -off compliance costs 
(conversion costs) of around EUR 9 280 000 and annual additional compliance costs of 
around EUR 8 160 000. T he Federal Statistical Office estimates that the two new 
information obligations envisaged – the written or electronic declaration when a functional 
barrier is waived in accordance with § 6a(3) and the obligation to provide evidence that 
MOAH transfer has been precluded in accordance with § 6a(5) – result in only minor 
costs.  
Table  1: Summary of compliance costs  
Provision  Requirement or information 
obligation  Balance annual 
cost  One-time 
conversion costs  
§ 6a(1) and 
(4) Functional barrier for food 
contact materials made from 
recycled paper   EUR 8 160 000  EUR 9 280 000  
§ 6a(3)  Written or electronic declaration 
on the waiver of functional 
barriers  Minor additional 
costs  - 
§ 6a(5)  Obligation to provide evidence 
that MOAH transfer has been 
precluded i n accordance with § 
6a(1), (2) and (4)  Minor additional 
costs  - 
 Total   EUR 8 160 000  EUR 9 280 000  
 
The result of the ex ante estimate is based on the following principles:  
The ex -ante estimate relates to two information obligations as well as a further 
requirement for trade and industry, all of which are derived from the new § 6a of the 
Consumer Goods Ordinance:  
 Recycled paper -based food contact materials may only be manufa ctured and put 
into circulation with a functional barrier (paragraph 1(1); paragraph 4). Exceptions to this 
rule apply if  
˗ in particular, there is such a low content of MOAH in the food contact material 
that it is not transferred to food (paragraph 2(1)).   - 10 - As at: 14/08/2020 Time:  15:07 
˗ other suitable measures have been taken to prevent a transfer from MOAH to 
food (paragraph 2(2)).  
 If the food business operator himself uses a functional barrier (intermediate bag or 
similar) or takes other measures to prevent the transfer of MOAH to food and he therefore 
does not require the manufacturer or distributor of the food contact article to equip the 
food contact article with a functional barrier, he must submit a written or electronic 
declaration to the manufacturer or distributor of the food con tact material prior to delivery 
of the food contact material (paragraph 3).  
 Obligation to provide evidence that MOAH transfer has been precluded (paragraph 
5).  
The present estimate followed the ‘Guidelines for determining and presenting the 
compliance costs in regulatory projects of the Federal Government’1. Companies and 
research institutions were interviewed by telephone to estimate the number of cases as 
well as the time and material expenditure. The calculation of the number of cases includes 
data f rom official statistics.  
Functional barrier for food contact materials according to § 6a(1) and (4)  
a) One -off conversion costs  
The reorganisation costs include personnel and material costs for the initial testing of 
foodstuffs and food contact materials  as well as for the development, testing and 
commissioning of suitable packaging in accordance with § 6a .  
 Number of cases  
To derive the number of cases (= affected products: food plus food contact materials that 
come into contact with it), both data obta ined from interviews and the cost structure 
survey in the manufacturing sector were used.2 On the basis of the interviews, data on the 
number of products of individual companies could be obtained. The companies’ sales 
figures were taken from publicly avail able sources. Based on these values, the turnover 
per product was determined for five companies, amounting on average to around EUR 2.5 
million. The cost structure survey contains information on the number and turnover of 
companies in the branches of the m anufacturing industry (according to the Classification 
of Industry Sectors, 2008 edition). On the basis of the information from the interviews, 
seven affected economic sectors could be identified:  
Production of  
• Starch and starch products  
• Preserved p astry goods and cakes  
• Pasta  
• Confectionery  
• Coffee, tea  
• Ground and peeled products  
• Ready meals  
 
The total turnover of the 415 companies affected amounts to around EUR 26 billion.  
On the basis of the total turnover, it is estimated how many p roducts (= food plus 
associated food commodity) these companies produce for the German market: with a total 
turnover of EUR 26 billion and a turnover of EUR 2.5 million per product, this gives 
                                                
1  Federal Statistical Office (2012): Guidelines for determining and presenting the compliance costs in 
regulatory projects of the Federal Government.  
2  Cost structure survey in the field of manufacturing, mining and quarr ying of stones and earth (EVAS 
No. 42251): Employees, turnover, production value and value added of companies in the 
manufacturing sector, Germany 2015, economic sectors WZ08 -10.   - 11 - As at: 14/08/2020 Time:  15:07 
around 10,000 products . Only part of the product packaging actu ally needs to be 
changed, because the companies are not all equally affected: While some companies 
have to convert their entire product range, others only have a few products affected. 
However, it must be checked for all products whether the existing packa ging sufficiently 
prevents the transfer of MOAH to the food. Food packaged exclusively in foil is also tested 
because these products are usually further packaged and delivered in cardboard boxes 
made from recycled waste paper.  
 
 Material costs  
 
The material costs are made up of the analysis costs for the initial testing of foodstuffs and 
associated food contact materials (usually packaging) as well as the development and use 
of new packaging. The costs arise from commissioning external laboratori es for the 
examinations. Few companies carry out the analyses completely themselves. The total 
costs for all affected products of a company were requested and these total costs were 
allocated to the number of products of the company falling within the scop e of the 
Ordinance.  
On the basis of the interviews, it was determined that the inspection of the food and 
associated food contact items was around EUR 290 per product  will cost. The costs 
apply to all 10 000 products.  
It is assumed that the packaging has t o be changed for 50% of the products tested, i.e. for 
5 000 products. For this purpose, an average of EUR 550 material costs per product  
would arise.  
Thus, the one -time material costs are shown by from the following calculation:  
EUR 290 inspection costs x 10 000 products to be tested + EUR 550 material costs x 5 
000 product packages to be converted = EUR 5 650 000.  
 
 Personnel costs  
 
The personnel costs consist of the time required to test the food and the associated food 
contact materials (usually packagi ng) as well as for the conversion of packaging 
(preparation and follow -up of the laboratory tests; the analysis itself is mainly carried out 
externally). The total costs for all affected products of a company were requested and 
these total costs were alloc ated to the number of products of the company falling within 
the scope of the Ordinance.  
On the basis of the interviews, it was calculated that testing the food and associated food 
contact items would take around three hours per product . In addition to the  analysis for 
MOAH, this also includes preparatory work such as sampling. The wage rate is set at 
EUR 60.50 / hour.3 These costs are incurred for all 10 000 products.  
The time required to convert a product packaging is approx. six hours of work per 
product . The wage rate is set at EUR 60.50 / hour.3 Assuming that around 50% of all 
products have to be converted, labour costs are incurred for 5 000 products.  
Thus, the one -time personnel costs result from the following calculation:  
3 hours of testing time x E UR 60.50 wage rate x 10 000 products to be tested + 6 hours 
conversion costs x EUR 60.50 wage rate x 5 000 products to be converted = EUR 3 630 
000. 
 
Table  2: Overview of the conversion costs  
Requirement/informatio
n obligation (IP)  One-
time 
time 
expendit
ure in Wage rate 
in 
EUR/hour  One-time 
personnel 
costs in 
EUR  One-time 
material 
costs in 
EUR  One-time 
complian
ce costs 
in EUR  
                                                
3  Wage cost tables 2017 for compliance and administrative cost measurement of the Federal 
Statistical Office, branch of industry C10, companies with at least 250 employees, high qualification 
level.  
  - 12 - As at: 14/08/2020 Time:  15:07 
hours  
Functional 
barriers  Article  6a(1) 
and (4)  60 000  60.50  3 630 000  5 650 000   9 280 000  
 
b) Annual compliance costs  
 
The annual compliance costs include personnel and material costs for the periodic 
inspection and the additional costs due to the regulation -compliant packaging solution in 
accordance with § 6a. The periodic testing of food and packaging solutions includes 
sampling, analysis and evaluation.  
 
 Number of cases  (= affected products: food plus food contact materials that come 
into contact with it)  
 
The total number of products that are subject to the Ordinance is derived  according to the 
number of cases for the one -time conversion cost: 10 000 products are affected in 
principle; the packaging must be changed for 5 000 products. The conformity of the new 
packaging for these 5 000 products is checked annually. According to the companies 
surveyed, this cost is also incurred for the products that are not to be converted. It is 
assumed that the test corresponds to about a third of the cost for converted products.  
 
 Personnel costs  
 
The annual compliance costs result from the pe rsonnel costs for the tasks in the area of 
the periodic testing of food and the associated food contact items (usually packaging) 
(preparation and follow -up of the laboratory tests; the analysis itself is mainly carried out 
externally). The total costs for  all affected products of a company were requested and 
these total costs were allocated to the number of products of the company falling within 
the scope of the Ordinance.  
On the basis of the interviews, it was calculated that testing the food and associa ted food 
contact items would take around three hours per product annually. In addition to the 
analysis for MOAH, this also includes preparatory work such as sampling. The wage rate 
is set at EUR 60.50 / hour.3 
Based on the interviews, the products that hav e not been converted (50% of the total 
number, i.e. 5 000 products) are tested less intensively. The annual time expenditure 
corresponds accordingly to one hour per product . The wage rate is set at EUR 60.50 / 
hour.3  
The annual personnel costs are: 3 hour s of testing time x EUR 60.50 wage rate x 5 000 
products + 1 hour testing time x EUR 60.50 wage rate x 5 000 products = EUR 1 210 000.  
 
 Material costs  
 
The material costs are made up of the costs for the periodic inspection of foodstuffs and 
associated f ood commodities (usually packaging) and the additional costs for packaging 
to be converted. The costs arise from commissioning external laboratories for the 
examinations. Few companies carry out the analyses completely themselves. In each 
case, the costs f or all affected products of a company were requested and these total 
costs were allocated to the number of products of the company falling within the scope of 
the Ordinance.  
On the basis of the interviews, it was determined that annual costs for the inspe ction of 
foodstuffs and associated food contact items of around EUR 290 per product will be 
incurred. These material costs are incurred for 5 000 products. For the less intensive 
testing of the foods that were not to be converted, around EUR 100 per produc t was 
calculated, which are incurred for 5 000 products.  
The additional costs for packaging material for the 5 000 products to be converted amount 
to around EUR 1 000 per product .   - 13 - As at: 14/08/2020 Time:  15:07 
The annual material costs are: EUR 290 testing costs x 5 000 products + EU R 100 testing 
costs x 5 000 products + EUR 1 000 material costs x 5 000 products = EUR 6 950 000.  
 
Table  3: Overview of ongoing compliance costs  
Requirement/informati
on obligation (IP)  
 Annual 
time 
expenditu
re in 
hours  Wage rate 
in 
EUR/hour  Annual 
personnel 
costs in 
EUR  Material 
costs 
annually 
in EUR  Annual 
complian
ce costs 
in 
thousand
s of EUR  
Functional 
Barrier  Article  6a(
1) and (4)  20 000  60.50  1 210 000  6 950 000   8 160 000  
 
Written or electronic declaration on the waiver of a functional barrier as per § 6a(3)  
 
a) One -off conversion costs  
 
There are no one -time conversion costs.  
 
b) Annual compliance costs  
 
The required additional information, i.e. the content of a waiver,  will already be discussed 
between packaging and food manufacturers as part of the agreements on the packaging 
material. The additional compliance costs that arise are insignificant.  
 
Obligation to provide evidence that MOAH transfer has been precluded in  
accordance with § 6a(1), (2), and (4)  
 
a) One -off conversion costs  
 
There are no one -time conversion costs.  
 
b) Annual compliance costs  
 
A general documentation requirement for food contact materials is already laid down in 
Commission Regulation (EC) No. 2023/2006 of 22 December 2006 on good 
manufacturing practice for materials and objects intended to come into contact with food 
(OJ L 384 o f 29 December2006, p. 75) (the GMP Ordinance). In addition, the initial test 
and the periodic tests of the food and food packaging already produce documents that 
can serve as evidence. The additional compliance costs that arise are insignificant.  
 
The prov isions of the Ordinance apply equally to small and medium -sized enterprises 
(SMEs). Special exceptions for SMEs are not possible for reasons of consumer health 
protection. However, the Ordinance provides for general exceptions for the use of a 
functional b arrier, provided that the necessary conditions are met.  
 
The one -off compliance costs for businesses resulting from the planned regulations is 
subject to application of the ‘one -in, one -out’ rule. Compensation cannot be rendered 
within the scope of this ar rangement. The compliance costs are therefore compensated 
for another regulatory project.  
 
c) Implementation costs for citizens  
 
No compliance costs will be incurred by citizens as a result of this Ordinance.  
  - 14 - As at: 14/08/2020 Time:  15:07 
5. Additional costs  
A minimal impact on individua l prices cannot be completely ruled out; however, an impact 
on the general price level, in particular on the consumer price level, is not to be expected.  
6. Other legal consequences  
The Ordinance does not contain any provisions which specifically impact the l ife situation 
of men and women. Equal consideration is given to protecting the health of men and 
women. Therefore, no impact on male/female equality is anticipated.  
VII. Time limitation; evaluation  
The Ordinance is not limited in time, as the protection of consumers must be ensured over 
the long term.  
Evaluation of the impact of this Ordinance is envisaged within five  years of the application 
of the provisions. This is to check whether the aim of th e Ordinance has been achieved, 
i.e. the minimisation of consumer exposure to MOAH from the food contact materials 
regulated in the Ordinance through the use of functional barriers or other suitable 
measures to prevent the transfer of MOAH (detection limit of 0.5 milligrams MOAH per 
kilogram of food or 0.15 milligrams MOAH per kilogram of food simulant). The necessary 
data should be available on the basis of the results of the controls by the food control 
authorities and the conformity work of the companies concerned. Furthermore, the actual 
cost effects, such as the costs of the development, conversion and analytical checking of 
the food contact materials and affected foods, should be included in relation to the 
regulatory objective and any possible side eff ects. Developments in terms of analysis, in 
particular the achievable detection limits for MOAH, should also be considered.  
B. Specific part  
Re Article  1 
Re (1)  
The definitions for waste paper stock, aromatic mineral oil hydrocarbons (MOAH), 
functional barriers and food simulants are added in point (1) in light of the content of this 
Ordinance.  
As part of the definition of the functional barrier, a differentiatio n is made with regard to the 
various forms. A functional barrier can be permanently connected to the food contact 
material, for example in the form of a coating (§ 2(9)(a)), or it can be separate, for 
example in the form of an intermediate bag (§ 2(9)(b)).  Depending on the type of food 
contact material, the food, the conditions of use and the period of use of the food contact 
material, aluminium or various plastics (e.g. PET, polyacrylates, polyacetates, 
polyamides) are suitable as a material for coating pa per, paperboard or cardboard, or as a 
material for an additional inner bag, for example.  
Re (2)  
(2) specifies specific provisions for food contact materials made of paper, paperboard or 
cardboard that are made using recycled paper.  
Paragraphs 1 and 2 of § 6a contain specific requirements for the food contact materials 
operator (manufacturer, distributor). If the food business operator wishes to take his own  - 15 - As at: 14/08/2020 Time:  15:07 
precautions that deviate from this, the requirements of paragraphs 3 and 4 addressed to 
him and the  food contact material operator apply. Paragraph 5 is aimed at both the food 
contact material operator and the food business operator.  
According to § 6a(1), the above -mentioned food contact materials must be equipped with 
a functional barrier to ensure tha t MOAH does not transfer to food. Manufacturers and 
distributors of food contact materials will usually use a functional barrier according to § 
2(9)(a), i.e. a layer or coating that is firmly attached to the food contact material. If transfer 
to the food i s measured, it is specified by law that no transfer takes place up to a detection 
limit of 0.5 milligrams of MOAH per kilogram of food. If the functionality of the barrier is 
determined using suitable food simulants, a corresponding detection limit of 0.15  
milligrams of MOAH per kilogram of food simulant applies.  
The analysis of mineral oil in food and the proportion of the food contact material is 
difficult, but great progress has been made in recent years. A long -term targeted detection 
limit of 0.15 mill igrams per kilogram of food for the transfer of MOAH from food contact 
articles cannot currently be achieved in all foods. It is heavily influenced by the respective 
food matrix. The intended detection limit of 0.5 milligrams MOAH per kilogram of food for 
the transfer from food contact articles can currently be determined analytically in practice 
in food. If, on the other hand, food simulants (usually poly (2.6 -diphenyl -p-phenylene 
oxide)) are used to check whether the barrier is functional to prevent the t ransfer of 
MOAH, a detection limit of 0.15 milligrams of MOAH per kilogram of food simulant is 
required. This is also due in particular to the fact that the effects of the food matrix that 
occur for MOAH do not apply, and thus MOAH can be detected in a muc h more sensitive 
manner in practice. With regard to the convention methods and the analysis methods 
currently mainly used, reference is made to the following publications by the Federal 
Institute for Risk Assessment:  
 ‘Determination of hydrocarbons from mi neral oil (MOSH and MOAH) or plastics 
(POSH, PAO) in packaging materials and dry food using solid phase extraction 
and GC -FID’ (available at: http:// www.bfr.bund.de/cm/343/bestimmung -von-
kohlenwasserstoffen -aus-mineraloel -oder-kunststoffen.pdf ; as of: Insert 
XX.YY.2020 ); 
 ‘Mea surement of mineral oil - hydrocarbons in food and packaging materials’, 
compendium of the BfR and the Zurich Cantonal Laboratory (available at: 
http://www.bfr.bund.de/cm/343/message -von-mineraloel -kohlenwasserstoffen -in-
lebensmittel -und-verpackungsverbindungen.pdf ; as of Insert XX.YY.2020 ).  
The requirements for the use of a functional barrier only apply to materials and objects 
made of paper, paperboard or cardboard that have been manufactured using recycled 
paper that fall within the scope of Article 1(2) of Regulation (EC) No. 1935/2004 on 
materials and articles intended to come into contact with food and repealing Dire ctives 
80/590/EEC and 89/109/EEC. They only apply to transport and outer boxes if the specific 
case involves food contact materials. An overlapping, multiple application of a functional 
barrier along the supply chain is generally not necessary. For example , in the case of 
transport boxes and outer boxes – if they are food contact materials in the specific case – 
a functional barrier is not necessary if the design of the actual packaging or the packaging 
system of the food itself (e.g. primary or secondary p ackaging) ensures that there is no 
transfer from MOAH to food. Correspondingly, as is generally the case with food contact 
materials, adequate communication within the supply chain is essential.  
The detection limit of 0.5 milligrams MOAH per kilogram of f ood stipulated in this 
Ordinance in connection with the functional barrier only relates to a transfer from MOAH 
from the food contact materials covered by the scope of this Ordinance to food and does 
not constitute a general maximum amount of MOAH in food.    - 16 - As at: 14/08/2020 Time:  15:07 
Paragraph 2 provides for exceptions to the mandatory equipping of the food contact 
materials in question with a functional barrier by the food contact materials operator: If 
there are special requirements that prevent the transfer of MOAH to food, or if other 
measures ensure that the transfer of MOAH from the food contact material is not 
detectable with a detection limit of 0.5 milligrams MOAH per kilogram of food (or 0.15 
milligrams MOAH per kilogram of food simulant), there is no obligation to use a fun ctional 
barrier. For example, the former may be the case if the MOAH content in the paper, 
paperboard or cardboard itself is already so low that it cannot be transferred to food above 
the detection limit. Examples of the latter, i.e. other suitable measure s as defined by (2) 
include measures applying to the food contact material, such as the incorporation of 
adsorbents (activated carbon or similar) in the paper, paperboard or cardboard, which 
prevent MOAH from being transferred to the food.  
According to § 6a(3), in deviation from § 6a(1), taking into account paragraph 4, the 
relevant food contact materials may be manufactured and placed on the market without a 
functional barrier that is permanently connected to the food contact material. However, 
this is on ly permissible if the food business operator declares (in written or electronic form) 
to the manufacturer or distributor of this food contact material that he will dispense with a 
functional barrier before delivery of a food contact material. This declarat ion must be kept 
by the manufacturer or the person placing the food contact material on the market in order 
to be able to prove to the competent authority that the provision of § 6a(1)(1) could be 
deviated from due to the waiver by the food business operat or.  
The provision of § 6a(3) covers food business operators who, in their area of 
responsibility, bring food contact materials that have been manufactured using recycled 
paper into direct or indirect contact with food, i.e. wrap or package food, or bring food into 
contact with a food contact material for the first time in another way. However, the 
obligation under § 6a(3) does not apply, for example, to food business operators who only 
purchase previously packaged food (including from another EU member sta te or a non -
member state) and for whom the packaging process is beyond their control. In this case, 
however, the food business operator must ensure, as part of his general duty of care, that 
the products in question meet the requirements relating to the im permissible transfer of 
MOAH.  
In the cases of § 6a(3), the food business operator himself must take appropriate 
measures in accordance with § 6a(4) to preclude transfer of MOAH from the food contact 
material to the food. Thus, the food business operator ca n use an intermediate bag or 
similar which serves as a functional barrier while filling the food, for example (see § 
2(9)(b). The requirements for the detection limit apply accordingly.  
However, the use of a functional barrier is not the only way to ensure  that no transfer of 
MOAH from the food contact material to the food takes place or that no such transfer is 
detectable. In particular, there is no obligation to take appropriate measures if, due to the 
nature of the food (e.g. table salt) or the condition s of use (e.g. in the case of frozen food 
or short -term contact with dry food), a transfer from MOAH to food does not take place or 
is not above the detection limit and is therefore considered undetectable.  
As part of the general provisions on food contact materials, the responsible entrepreneur 
in question – e.g. the manufacturer, the distributor or the food packager – must, in fulfilling 
his due diligence duty, ensure that the food contact materials in or u sed in his area of 
responsibility meet the relevant requirements. Reference is made, for example, to § 30(3) 
of the Food, Consumer Goods and Feed Code (LFGB) and Regulation (EC) No. 
2023/2006. According to Regulation (EC) No. 2023/2006, certain documentati on 
requirements (among other things) must be fulfilled. With regard to this Ordinance, this is 
relevant for the question of the barrier to be used or for the application of the exemption, 
because the documents that are drawn up as part of these obligations  can also serve as 
evidence that the barrier has the required functionality with regard to MOAH for the  - 17 - As at: 14/08/2020 Time:  15:07 
intended purpose, or, if no functional barrier is used, that a transfer from MOAH from the 
food contact material to food cannot be detected, i.e. does n ot exceed the detection limit.  
The manufacturer or distributor of the food contact material and the food business 
operator are obliged to explain to the competent authority the conditions or circumstances 
on which an exception is based. § 6a(5) also contai ns an obligation (which clarifies the 
provisions above) for the manufacturers or the distributors of food contact materials and 
the responsible food business operators to provide documents that prove how the 
respective responsible person ensures that there  is no transfer from MOAH to food.  
§ 6a( 6) contains prohibitions on trade in foodstuffs to protect consumers from possible 
health hazards caused by the transfer of MOAH from food contact materials. The 
prohibitions on trade apply to food that has been handled with food contact materials that 
do not comply with § 6a(1)(1) or § 6a(4)(1), without one of the relevant exceptions under § 
6a(2) or § 6a(4)(3) applying.  
Re (3)  
(3) regulates the ban on the use of food contact materials that do not meet the 
requirements of § 6a.  
Re (4)  
(4) establishes the e nforcement of infringements of the provisions under §  6 of the 
Consumer Goods Ordinance.  
Re (5)  
(5) establishes that the provisions are only to be applied after a three -year transition 
period.  
(5) also stipulates that food contact materials that were manu factured in accordance with 
the provisions in effect before the date of application of the Ordinance may also be placed 
on the market and used for a further two years after this date.  
Re Article  2 
Article 2 contains the publication permit for the Consumer Goods Ordinance.  
Re Article  3 
Article  3 lays down the entry into force of the Ordinance.