FAQ - Frequently Asked Questions
According to Regulation (EU) 1169/2011, substances that cause allergies or intolerances must be indicated on pre-packaged foods. The threshold levels listed below, which are also used by official surveillance authorities as a basis for evaluating laboratory results, are intended to provide guidance on when an allergen must be declared as an ingredient.
| Allergen | Analytically determined as | Mandatory labeling as ingredient according to Regulation (EU) 1169/2011 |
|
Cereals containing gluten (wheat, rye, barley, oats, spelt, kamut) except: wheat-based glucose syrups, dextrose, wheat-based maltodextrins, barley-based glucose syrups, cereals for the production of alcoholic beverages |
Gluten | > 80 mg/kg |
| Eggs and products thereof | Whole egg powder | > 1 mg/kg |
| Peanuts and products thereof | Peanut | > 5 mg/kg |
|
Soybeans and products thereof except: fully refined soybean oil, natural tocopherols, plant oil-derived phytosterols, phytostanol esters from soybean oil sterols |
Full-fat soy flour | > 20 mg/kg |
|
Milk and products thereof (including lactose) except: whey for producing alcoholic beverages, lactitol |
Skimmed milk powder | > 2.5 mg/kg |
|
Treenuts and products thereof except: treenuts for producing alcoholic beverages Hazelnuts Cashew Almonds, walnuts, pecans, Brazil nuts, pistachios, macadamias, Queensland nuts |
As whole hazelnut, almond etc. |
> 5 mg/kg > 50 mg/kg > 20 mg/kg |
| Sesame seeds and products thereof | Unhulled sesame | > 10 mg/kg |
| Lupins and products thereof | Lupin | > 50 mg/kg |
| Celery and products thereof | Celery seed | > 20 mg/kg |
| Mustard and products thereof | Mustard seed | > 5 mg/kg |
These values are intended solely as guide values where the measurement uncertainty of the analytical methods must be considered.
Source: www.untersuchungsämter-bw.de
These values are intended solely as guide values where the measurement uncertainty of the analytical methods must be considered.
Source: http://www.untersuchungsämter-bw.de/pub/beitrag.asp?ID=878&subid=0&Thema_ID=9&lang=DE
The examination of the total germ count from hand swabs is not a suitable parameter for assessing the hygiene status, even after cleaning and disinfection, because the natural skin flora is not removed by hygienic hand disinfection. Enterobacteria are more suitable but can still not be completely reduced, depending on individual skin structure. Depending on the operation, it may be advisable to investigate specific parameters such as E. coli or Staphylococcus aureus. It should be considered that hands can also be contaminated by contact with raw animal or plant foods.
Allergies to wheat and peanuts are generally known in food products. However, skin contact with these substances can also lead to the development of corresponding allergies. For this reason, the EU has regulated the use and quality of wheat proteins and peanut oils.
Regulation (EU) 2017/2009 amending Annex III of the EU Cosmetic Regulation defines limits for these ingredients. From September 25, 2018, cosmetic products placed on the market must meet the aforementioned requirements.
Peanut oils used in cosmetics may only contain a maximum concentration of 0.5ppm of peanut proteins. The restriction for hydrolyzed wheat proteins depends on the average molecular mass of the peptides. The maximum value for the average mass is 3.5 kDa.
The exact text of Regulation (EU) 2017/2009 can be found under the following link.
Source: European Union
Recommendations include e.g. mozzarella, brined cheese, raw meat, meat products, casings, fish and fish products, soft and shellfish, instant and dried products, ready meals, prepared dishes, delicatessen products, cereal products, bread, bakery and pastry goods, pasta, dried fruits, oilseeds, nuts, mixed salads, fruit salads, herbs and spices, ice cream and chocolate.
Owners of a water supply facility (including private water supply) are required to have the water tested according to §14 of the Drinking Water Ordinance 2001. Examinations including sampling may only be carried out by authorized (accredited) testing laboratories.
An examination for legionella in drinking water installations is required when all of the following points are met:
- Presence of a large system for drinking water heating (= flow-through water heater with a content of more than 400 liters or more than three liters in at least one pipeline between the outlet of the water heater and the extraction point)
- The drinking water is supplied through a commercial (e.g. rental) or public activity (e.g. schools, hospitals, nursing homes)
- Atomization of the drinking water
In these cases, a systemic examination must be conducted. The obligation to conduct the examination always lies with the operator and other owners of the water supply system.
Microbiological criteria are included in several chapters of the Ph.Eur. Chapter 5.1.4 contains the acceptance criteria for non-sterile dosage forms (Table 1) as well as for raw materials used in their production (Table 2). Chapter 5.1.8 contains the acceptance criteria for herbal medicinal products for oral use.
Furthermore, many monographs of individual substances include specific acceptance criteria for microbiological quality.
Frequent detections occur, for example, in raw milk, fresh meat, spreadable raw sausage, soft cheese, leafy vegetables, and sprouts. Meat from ruminants and game is more frequently contaminated than pork.
Commonly contaminated are, for example, raw milk, raw milk cheese, semi-hard cheese, ready-to-eat sausages, pre-sliced cooked sausages, spreadable raw sausages, sliced packaged fruits or salads (ready-to-eat products), raw seafood, or smoked fish.
The publication is made in the form of a hygiene barometer, but also detailed contents of the inspections should be accessible to the citizens.
Further information can be found at www.ml.niedersachsen.de
The detection of germs in a cosmetic product always requires special attention. Contaminated raw materials, deficiencies in manufacturing, or even contamination of packaging materials can be causes.
Regardless of the detected quantity, identification should always be carried out. Only in this way can a risk assessment be conducted based on the number of microorganisms combined with the type of germ (risk group, hazard potential). This allows the question of the product's marketability to be answered.
Additionally, within the framework of a microbiological risk management system, one obtains information about possible sources of entry with the aim of avoiding similar contaminations in the future.
Art.8 of the EU Cosmetics Regulation stipulates that the manufacturing of cosmetic products must comply with GMP. Furthermore, the standard has quasi-legal status as it was published in the Official Journal of the EU (see also ISO 22716 available from Beuth Verlag).
According to Article 10 of the EU Cosmetics Regulation, a safety assessment is required for cosmetic products. This must be carried out by a suitably qualified person before the product is placed on the market. As part of the safety assessment, the regulation also requires a preservative efficacy test. (see Annex I point 3 of the EU Cosmetics Regulation)
According to Article 9 (1) (l) in connection with Article 55 of Regulation (EU) No 1169/2011 (FIC), a nutrition declaration has been mandatory on pre-packaged foods since 13.12.2016. Exempt from the mandatory nutrition declaration are foods listed in Annex V (e.g. tea, spices) of the FIC as well as beverages with an alcohol content >1.2 % vol.
If a nutrition declaration is voluntarily provided, it must comply with the requirements of the FIC. Consideration must also be given to requirements for specific foods such as mineral water, food supplements, or dietary foods.
Yes, the obligation to indicate allergens as per Annex II of Regulation (EU) No. 1169/2011 (FIC) also applies to non-prepacked foods. The German legislator has regulated additional national provisions for allergen labeling of non-prepacked foods with the Preliminary Food Information Supplementary Ordinance (VorlLMIEV).
If, for instance, an examination for food safety criteria according to Regulation (EC) No. 2073/2005 provides unsatisfactory results and also taking into account Article 14 of Regulation (EC) No. 178/2002 it is considered an unsafe food, the food must be withdrawn or recalled from the market.
The EU Commission has published 36 questions and answers regarding the aforementioned regulation. These provide a good overview of interesting issues.
Further information can be found at: ec.europa.eu
The purpose of the preservation challenge test is to confirm that the cosmetic product, when used as intended, prevents microbial growth and is thus microbiologically stable. However, it should be noted that preservation challenge tests are merely models and do not guarantee 100% safety.
The execution of a preservation challenge test is required by the EU Cosmetics Regulation as part of the safety assessment (see Annex I, Point 3 of the Regulation).
Exempt from the requirement to conduct a preservation challenge test are products that meet one or more of the following conditions.
- pH value: <3
- pH value: >10
- water-free products
- alcohol content: >20%
- filling temperature: >65°C
- water activity: <0.75
- solvent-based products
- oxidizing products
- aluminum chlorohydrate content: >25%
Other low-risk products may be identified as part of an individual risk assessment.
