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.

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.

Certain toxin-producing strains of E.coli can cause diarrhea and more severe illnesses in humans, such as hemolytic uremic syndrome (HUS). Kidney failure and even death can result from this condition.

Listeria monocytogenes can easily overcome anatomical barriers in the body and, for example, penetrate the intestines, the blood-brain barrier, or the placenta without any problems.

For those affected by listeriosis, the disease is associated with a comparatively higher damage than with other foodborne infection pathogens (e.g., fever, muscle pain, gastrointestinal diseases, meningitis, sepsis). The mortality rate is about 10-20% for the general population and up to 75% for risk groups (pregnant women, newborns, young children, immunocompromised adults, those taking immunosuppressants or stomach acid inhibitors).

These tests provide a statement about whether Listeria monocytogenes can multiply in the food. This statement is very important for manufacturers of ready-to-eat, perishable foods for two reasons:

1. As part of their duty of care, every food business operator must ensure that their products do not pose a health risk until the end of shelf life. Because Listeria monocytogenes is widely distributed in the environment, contamination with these bacteria cannot be completely ruled out in the production of many foods. It is therefore important to know whether Listeria monocytogenes can multiply in these foods during their shelf life. If the growth of Listeria monocytogenes is favored, the hygiene and safety levels during production must be even higher.
2. The Regulation (EC) 2073/2005 on microbiological criteria requires in Annex I, Chapter 1 that certain food safety criteria for Listeria monocytogenes are met. Ready-to-eat foods that favor the multiplication of Listeria monocytogenes must not show Listeria monocytogenes presence in 5 samples of a batch, each 25g, at the production level (Criterion 1.2 in Chapter 1 of Annex I). If this is not complied with or this food safety criterion is exceeded, and the ready-to-eat food is already on the market, a public recall is threatened.

However, if ready-to-eat food does NOT favor the multiplication of Listeria monocytogenes, it is sufficient according to this regulation that the food safety criterion of 100 CFU/g is not exceeded in 5 sub-samples of the batch at the production level.

For ready-to-eat foods with a pH value of ≤ 4.4 or an aw value of ≤ 0.92, the food safety criterion of 100 CFU/g applies directly at the production level. The same applies if the ready-to-eat products have a pH of ≤ 5.0 and an aw of ≤ 0.94 or have a shelf life of less than 5 days. This is noted in the footnotes of Chapter 1 of Annex I of Regulation (EC) 2073/2005, as it is assumed in these cases that Listeria monocytogenes does not grow under these conditions, or the food safety criterion of 100 CFU/g for Listeria monocytogenes in ready-to-eat foods at the trading level is not exceeded.

The food business operator must provide this proof of the growth potential of Listeria monocytogenes in ready-to-eat foods to the authority. Otherwise, in case of doubt, the authority must assume that the stricter criteria for Listeria monocytogenes ("not detectable in 25g in each of 5 sub-samples of the batch") must be complied with for the products.

To provide this proof to the authority, contamination or challenge tests are required for many perishable foods unless the ready-to-eat food meets the above-mentioned chemical-physical properties or has a shelf life of less than 5 days.

Environmental investigations help to assess the internal hygiene status. They allow hazards to be recognized and preventive measures to be initiated for the production of hygienically impeccable food. The obligation for sampling in processing areas and equipment used in food production, especially for Listeria monocytogenes, is regulated by Art. 5 of Regulation (EC) No. 2073/2005.

Since no minimum infectious dose can be determined for Salmonella, the absence of Salmonella is required in ready-to-eat foods. As a food safety criterion according to Annex I Chapter 1 of Regulation (EC) No. 2073/2005, the absence of Salmonella in 25g (or 10g) of food is always required. A quantitative determination is therefore not sufficiently informative for the microbiological assessment of foods.

In a simple descriptive sensory test, the food is checked for conformity with general consumer expectations based on appearance, smell, and taste. The test can be used alongside other studies to determine the shelf life and to detect spoilage or deterioration of food. Microbiological findings of spoilage organisms can often only be criticized in connection with sensory tests.

The best-before date of a food product is defined in Regulation (EU) No. 1169/2011 (Food Information Regulation, FIR) as the date until which the food retains its specific properties under proper storage conditions. The manufacturer thus guarantees that the food will have the same quality as when it leaves the company up to this point.

According to FIR, this is a mandatory indication on the labeling of prepackaged food. Annex X of the FIR specifies how the best-before date is to be stated:

1. The date consists of the day, month, and, where applicable, the year in this order. If the shelf life is less than three months, indicating the day and month suffices. For foods with a shelf life of three to eighteen months, indicating the month and year is sufficient. Foods with a shelf life of more than eighteen months only need to be marked with the year.
2. The date must be preceded by "best before..." if the day is stated, and "best before end..." in all other cases.
3. A note indicating where to find the date on the label is possible (e.g., "best before: see lid").
4. The best-before date must be supplemented by the storage conditions if these are necessary to guarantee the stated shelf life.

Exemptions from the requirement to provide a best-before date are granted for the following foods:

• untreated fresh fruits and vegetables, including potatoes but not sprouts of seeds and similar products
• wine, liqueur wines, sparkling wines, aromatized wines, and similar products from fruits other than grapes, as well as beverages obtained from wine grapes or grape must
• beverages with an alcohol content of 10 or more percent by volume
• bakery products that are consumed within 24 hours of manufacture
• vinegar
• table salt
• sugar and sugar confectionery
• chewing gum

If you have any questions, our customer advisors are happy to assist you.

The examination for L. monocytogenes must be carried out both on equipment with food contact and in production areas without direct contact. Particularly hard-to-reach areas, porous, uneven materials, water accumulations (e.g. drains), and equipment and devices that are difficult to clean, where food residues can accumulate, should be taken into account. Swab and sponge samples are suitable for sampling. To increase the likelihood of detection, sampling should be done during processing, i.e., before cleaning and disinfection.
Raw material examinations, intermediate and final product controls can also be part of Listeria monitoring.

A technical guideline (EURL Lm TECHNICAL GUIDANCE DOCUMENT for conducting shelf-life studies on Listeria monocytogenes in ready-to-eat foods) was published by the EU Commission, which describes the procedure for conducting challenge tests with Listeria monocytogenes.

Some important aspects of it:

• The conditions during the shelf life must be considered (including foreseeable changes compared to the information on the packaging, such as refrigerator temperatures in households).
• A mixture of at least 2 strains of Listeria monocytogenes should be used for contamination. Not only laboratory strains should be used, but also strains isolated from similar foods or even from the respective food company.
• The food should be contaminated at the beginning of the challenge test with a germ concentration of about 100 CFU/g.
• DIN EN ISO 20976-1:2019-09 (https://www.beuth.de/de/norm/din-en-iso-20976-1/297296778)

The abbreviation stands for "Rapid Alert System for Food and Feed".

It is an EU-wide rapid alert system for food, feed, and consumer goods of the European Commission. The RASFF was launched in 1979 and enables the efficient exchange of information and notifications between its members (including 28 EU member states and Switzerland).

Various forms of notifications are distinguished.

• Alert notifications contain information that requires immediate action, as this product poses a serious risk to human health and is already on the market.
• Information notifications include information where no immediate action is required, but their dissemination is of interest to the member states.
• Notifications on border rejections and news of general interest

The abbreviation stands for "Arbeitskreis Lebensmittelchemischer Sachverständiger der Länder und des Bundesamtes für Verbraucherschutz und Lebensmittelsicherheit," which translates to "Working Group of Food Chemistry Experts of the States and the Federal Office for Consumer Protection and Food Safety."

The working group consists of representatives from state testing facilities as well as the Bundeswehr (German Federal Armed Forces).

Representatives from the Federal Ministry of Food and Agriculture (BMEL) or the Federal Institute for Risk Assessment (BfR) are consulted as guests.

Furthermore, the ALS works closely with the ALTS to achieve harmonizing results on joint issues.

The main task essentially involves examining and assessing products subject to the German Food and Feed Code.

The responsibilities of the ALS include, among other things, topics such as the composition and labeling of food, drinking water, or residues and contaminants, as well as the corresponding food analysis.

Source: www.bvl.bund.de

The ALTS is a panel of experts at the federal-state level. The abbreviation stands for “Working Group of Experts on Food Hygiene and Food of Animal Origin.”

The panel consists of representatives from official testing institutions, the military, counter-sample experts, and employees of federal research institutions. The main task is essentially to exchange experiences and opinions, as well as to aim for harmonization in the assessment of test results. The areas of responsibility for the ALTS include topics such as the composition of food of animal origin, food hygiene and microbiology, as well as food analysis.

The term "connective tissue protein-free meat protein" (abbr: BEFFE) is defined in the guidelines for meat and meat products. It is considered a measure for the pure muscle meat content in a meat product. The guidelines specify a minimum value for many meat products. Falling below this value may constitute misleading information.

The German regulation on requirements for hygiene in the production, treatment, and marketing of food (LMHV) applies in addition to European hygiene law. It regulates, for example, the supply of small quantities of certain primary products or the production of traditional foods. In the LMHV, for example, the term "perishable food" is defined. Additionally, the Animal Food Hygiene Regulation (Tier-LMHV) applies with hygiene requirements for animal-based foods. 

Regulation (EU) No 1169/2011 is also known as the Food Information Regulation (FIR). It governs any information that concerns food and is made available to the end consumer. It includes, among other things, requirements for mandatory nutrition and allergen labeling.

The Regulation (EC) No 1223/2009 is the overarching EU cosmetics regulation. It contains rules that every cosmetic product must meet in order to be placed on the market in the EU. The aim of the regulation is to achieve a high level of health protection and a functioning internal market for trade in cosmetic products. The Regulation (EC) No 1223/2009 has direct legal effect in all EU member states and applies to importers, manufacturers, and distributors of cosmetic products.

The Regulation (EC) No. 2073/2005 on microbiological criteria for foodstuffs establishes sampling frequencies and microbiological limits (process hygiene and food safety criteria). It is directed at food business operators and sets the legal minimum requirements for the microbiological quality of certain foods. These include, for example, ready-to-eat meals, carcasses, meat preparations, milk and dairy products, egg products, and cut fruit and vegetables.

The Regulation (EC) No. 852/2004 on the hygiene of foodstuffs is the general European hygiene regulation. It includes basic rules for the hygienic production of food. The annex provides specific details such as requirements for personnel hygiene, spatial facilities, equipment, and hygiene in handling food. The regulation contains, among others, a registration requirement, according to which every food-producing business must be registered with the responsible authority. In addition to the general principles of Regulation (EC) No. 852/2004, specific hygiene regulations of Regulation (EC) No. 853/2004 apply to EU-approved establishments producing animal products. Furthermore, the German Food Hygiene Ordinance (LMHV) and the Animal Food Hygiene Ordinance (Tier-LMHV) also apply nationally in Germany.

A critical control point (CCP) is a step or stage in food production where it is possible and essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level.

A system to ensure food safety. It is based on the principles of hazard analysis and the control of critical control points (CCPs). These principles are established in a document of the Codex Alimentarius, as well as in Art. 5 of Regulation (EC) No 852/2004.

Listeria monitoring refers to the targeted sampling of processing areas and equipment for L. monocytogenes in a food establishment and its documentation. The goal is to detect and eliminate persistent strains of Listeria in the facility to prevent food contamination.

A regularly conducted sampling to record the company's internal hygiene status. The monitoring can include, for example, the inspection of personnel, facilities and equipment, indoor air, and water used in production.

Persons employed in kitchens of restaurants and communal catering facilities, and employees from food companies who come into contact with the following foods: meat, milk, fish, delicacies, salads, egg products, ice cream, baked goods with non-heat-treated components, sprouts and seedlings, must prove a preliminary instruction according to §43 para. 1 of the Health Office or by a doctor commissioned by the Health Office before starting their work. This also applies to trainees, (seasonal) temporary workers, interns, etc.

Subsequent instructions according to § 43 para. 4 IfSG can be carried out within the company (contents e.g. in DIN 10514). Hygiene training including subsequent instruction according to IfSG can also be conducted by employees of the BAV Institute in your company. Furthermore, the BAV Institute also offers corresponding training (NOT preliminary instruction!) via an internet portal: www.bav-onlineschulung.de

The "primary ingredient" of a food product is the ingredient that makes up more than 50% of the food product or the one that is usually associated by the consumer with the name of the food product and for which a percentage indication is required in most cases.

This definition is found in Article 2 (2q) of Regulation (EU) 1169/2011 (Food Information Regulation - FIR).

According to current understanding, examples of primary ingredients in certain food products include:

• Grain flour in baked goods
• Durum wheat semolina in pasta
• Fruits in fruit yogurt
• Pork in cooked ham

Fipronil is a biocide and acts as a highly toxic insecticide against fleas, mites, lice, and roaches. It is used as a contact poison mainly in pet care products to prevent and treat infestations of parasites.

Fipronil is not approved for use in food. Therefore, it may not be applied as a pesticide or veterinary drug in agriculture (exceptional permits exist, e.g. for combating wireworms in potatoes).

Products contaminated with Fipronil, regardless of the level of contamination, are considered unfit for sale and must be withdrawn from the market. According to a statement from the BfR (Federal Institute for Risk Assessment), a potential health risk cannot be ruled out at concentrations greater than 0.72 mg/kg of food.

The term refers to non-prepackaged foods. This particularly includes foods that are sold loose, as well as foods that are packaged at the consumer's request at the point of sale and those that are sold immediately after packaging.

Commercially available double-sided ready-to-use nutrient media suitable for pressing onto smooth surfaces. They are used, for example, for examining the aerobic mesophilic germ count (total germ count) and Enterobacteriaceae to check successful cleaning and disinfection according to DIN 10516. Contact samples should not be used for the specific determination of pathogenic germs. Swab and sponge samples are better suited for this purpose.

Sterile cotton swabs suitable for semi-quantitative testing for any germs in hard-to-reach areas and on non-smooth surfaces. This method allows the identification of numerous target organisms both qualitatively and semi-quantitatively.

The requirements for microbially low-risk products are described in the standard ISO 29621 "Guidelines for the risk assessment and identification of microbiologically low-risk products". 

These are products that, due to their physicochemical properties, inhibit the growth of microorganisms or kill them.
These are products that meet one or more of the following requirements.

• pH-value: <3
• pH-value: >10
• anhydrous 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 can be identified as part of an individual risk assessment.
For microbiologically low-risk products, a preservative efficacy test is not necessary as part of the safety assessment.

In these tests, the food product is contaminated with specific bacteria. In this case, it is conducted with various strains of Listeria monocytogenes. Subsequently, the product is stored over its shelf life under real conditions and regularly tested for these bacteria.

Biofilms are communities of bacteria, fungi, protozoa, or algae that attach to surfaces in aqueous systems, grow there, and form a slime layer. This layer usually consists of polysaccharides and protects the underlying microorganisms from influences such as disinfectants or high temperatures.

If you would like to learn more about biofilms, we recommend the following interesting information sources:

Fraunhofer Institute

Biospektrum.de

Wikipedia

The German Society for Hygiene and Microbiology (DGHM e.V.) publishes microbiological reference and warning values, which provide an objective basis for businesses and authorities to assess the microbiological-hygienic status of a food product or a food group. DGHM recommendations exist for selected food groups. They are available for a fee at www.dghm-richt-warnwerte.de.