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Aktueller Stand des Arzneibuchs

Translation coming soon Das Arzneibuch ist eine Sammlung anerkannter pharmazeutischer Regeln über die Qualität, Prüfung, Lagerung, Abgabe und Bezeichnung von Arzneimitteln und den bei ihrer...

DE
Infoletter
10.03.2025

NEW

Verlängerung der Genehmigung verschiedener Biozidwirkstoffe

Translation coming soon Die EU-Verordnung über Biozidprodukte (EU) Nr. 528/2012 regelt das Inverkehrbringen und die Verwendung von Biozidprodukten wie Desinfektionsmitteln, Holzschutzmitteln oder...

EU
Infoletter

NEW

ALTS-Beschlüsse der 94. Arbeitstagung bezüglich tierischer Lebensmittel

Translation coming soon Die Stellungnahmen des Arbeitskreises der auf dem Gebiet der Lebensmittelhygiene und der Lebensmittel tierischer Herkunft tätigen Sachverständigen (ALTS) dienen als...

DE
Infoletter

ALTS-Beschlüsse der 94. Arbeitstagung bezüglich der Risikobewertung von Allergengehalten und Lebensmittelhygiene

Translation coming soon Die Stellungnahmen des Arbeitskreises der auf dem Gebiet der Lebensmittelhygiene und der Lebensmittel tierischer Herkunft tätigen Sachverständigen (ALTS) dienen als...

DE
Infoletter
07.03.2025

NEW

ALTS-Beschlüsse der 94. Arbeitstagung bezüglich Kennzeichnung

Translation coming soon Die Stellungnahmen des Arbeitskreises der auf dem Gebiet der Lebensmittelhygiene und der Lebensmittel tierischer Herkunft tätigen Sachverständigen (ALTS) dienen als...

DE
Infoletter
06.03.2025

NEW

Formale Berichtigung der Verordnung (EU) 2021/642 Änderung von Anhang III der Bio-Verordnung

Translation coming soon. Mit der Verordnung (EU) 2021/642 wurde Anhang III Nr. 2.1 der Verordnung (EU) 2018/848 (Bio-Verordnung) geändert. Der letzte Absatz von Nr. 2.1.3 bezieht sich auf Vorschriften...

EU
Infoletter

NEW

3 substances proposed for the SVHC candidate list

Regulation (EC) No. 1907/2006, or REACH for short, regulates, among other things, substances that are subject to authorisation. Before substances are included in the REACH Regulation for this purpose...

EU
(Legal) draft

Draft amendment to the electronic instructions for use for professional medical devices

Implementing Regulation (EU) 2021/2226 sets out conditions under which instructions for use may be provided electronically via the manufacturer's website instead of in paper form for certain devices...

EU
(Legal) draft

NEW

Draft amendment to the Feed Regulation published

The Feed Regulation serves to implement various legal acts of the European Community and the European Union relating to animal feed. This includes, among other things Regulations for undesirable...

DE
(Legal) draft

NEW

Draft amendment to the conformity assessment procedures for EU fertiliser products

Regulation (EU) 2019/1009 defines the provisions for making EU fertiliser products available on the market. EU fertiliser products are fertiliser products with CE marking. The conformity of an EU...

EU
(Legal) draft

NEW

Fifth amendment to the assessment basis for plastics and other organic materials in contact with drinking water

Materials and substances in contact with drinking water must fulfil certain hygiene requirements in accordance with the Ordinance on the Quality of Water for Human Consumption (Drinking Water...

DE
Infoletter
04.03.2025

NEW

Amendment of the Organic Regulation on oenological practices for the production of non-alcoholic wine

Part VI of Annex II to Regulation (EU) 2018/848 on organic production contains specific production rules for wine. To date, alcohol-free wine cannot be produced organically, as no dealcoholisation...

EU
Infoletter
04.03.2025

NEW

Extension of the approval of various biocidal active substances

The EU Regulation on biocidal products (EU) No 528/2012 governs the placement on the market and use of biocidal products such as disinfectants, wood preservatives or pesticides. The biocidal active...

EU
Infoletter

EU Supply Chain Directive (CSDDD) to be amended

Directive (EU) 2024/1760, better known as the Corporate Sustainability Due Diligence Directive (CSDDD), was officially published in the Official Journal of the EU on 5 July 2024 and came into force on...

EU
(Legal) draft

NEW

Amendment to Regulation (EU) No 10/2011 (Plastics Regulation)

Regulation (EU) No. 10/2011 (Plastics Regulation) sets out requirements for food contact materials and articles (LMBG) made of plastics. The amending Regulation (EU) 2025/351 now amends the Plastics...

EU
Infoletter

Formal rectification of the EUDR (Deforestation Regulation)

In the article referenced below, we reported on the publication of Regulation (EU) 2023/1115 on deforestation-free products. This corrigendum to this Regulation clarifies that Article 38(3) of the...

EU
Infoletter

NEW

Exemptions for thermal paper under the ORRChem will end soon

In the article referenced below, we reported on the amendment to the Chemical Risk Reduction Ordinance (ORRChem). Among other things, the ORRChem prohibits the use of bisphenol A and bisphenol S with...

CH
Reminder

Novel food calcidiol monohydrate approved as a source of vitamin D in food supplements

In the article referenced below, we provided information on the authorisation of calcidiol monohydrate as a novel food for use in food supplements. With this regulation, calcidiol monohydrate is now...

EU
Infoletter

NEW

New limit value for lead in products made from recycled soft PVC to apply soon

In the article referenced below, we reported on the restriction of lead in products made of polyvinyl chloride (PVC) in Annex XVII of Regulation (EC) No. 1907/2006 (REACH Regulation). The REACH...

EU
Reminder
27.02.2025

NEW

Rejection of a health claim

In accordance with Regulation (EC) No. 1924/2006, only health claims that are explicitly authorised may be used in food labelling and advertising. This Regulation now rejects the following health...

EU
Infoletter

Transition period for in-vitro diagnostics ends soon

In the article referenced below, we reported on the extension of some transitional periods of Regulation (EU) 2017/746 on in-vitro diagnostic medical devices (IVDR). Thus, certificates issued by a...

EU
Reminder

NEW

Explanatory guide to the scope of the ban on PFHxA

In the articles mentioned below, we reported on the inclusion of undecafluorohexanoic acid (PFHxA), its salts and PFHxA-related substances in Annex XVII of Regulation (EC) 1907/2006 (REACH). For PFHxA...

EU
Infoletter

NEW

Authorisation extensions and new authorisations for feed additives

Regulation (EC) No. 1831/2003 stipulates that additives for use in animal food must be authorised and governs the conditions and procedures for granting this authorisation. In addition, the Regulation...

EU
Infoletter

Transition period for in-vitro diagnostics ends soon

In the article referenced below, we reported on a further extension of the transitional periods of Regulation (EU) 2017/746 on in-vitro diagnostic medical devices (IVDR). In order for in-vitro...

EU
Reminder

UDI labelling for certain medical devices and in-vitro diagnostics becomes mandatory

In the article referenced below, we reported on Regulations (EU) 2017/745 on medical devices (MDR) and 2017/746 on in-vitro diagnostic medical devices (IVDR). In accordance with the regulations, the...

EU
Reminder

NEW

Safe packaging design for substances and mixtures

Regulation (EC) 1272/2008 (CLP Regulation) defines the requirements for the classification, labelling and packaging of hazardous substances and mixtures. This also includes specifications for the...

EU
fact sheet

NEW

Nicotine pouches and snus: current legal assessment

Nicotine pouches (nicotine pouches without tobacco) and snus (tobacco pouches for oral use) are used in a similar way. The bags are placed behind the upper or lower lip and removed from the mouth...

DE
fact sheet

Substance bans in cosmetics law

According to a study by the European Chemicals Agency (ECHA), many manufacturers of cosmetic products are not aware that, in addition to Annex II of Regulation (EC) 1223/2009 (EU Cosmetics Regulation)...

CH
EU
fact sheet

Borderline products guide on cosmetic products updated

Regulation (EC) No. 1223/2009 regulates requirements for cosmetic products. What is to be categorised as a "cosmetic product" is defined in the regulation. Nevertheless, from time to time products...

EU
Infoletter

Revised DGHM microbiological guide values and warning values published

In November 2024, the foodstuffs microbiology and hygiene specialised group of the German Society for Hygiene and Microbiology (DGHM) revised its microbiological guide values and warning values for...

DE
Infoletter

NEW

POP Regulation: Amendment of entries on PCBs and PBDEs

Regulation (EU) 2019/1021 on persistent organic pollutants (POPs Regulation) prohibits or restricts the manufacturing, placing on the market and use of certain POPs (persistent organic pollutants) in...

EU
(Legal) draft

Amendment to the Medical Devices Dispensing Ordinance

The Ordinance Regulating the Dispensing of Medical Devices (Medical Devices Dispensing Ordinance — MPAV) specifies which medical devices are subject to prescription or pharmacy requirements. It also...

DE
Infoletter

Corrigendum to the Regulation amending the use and specifications of sorbic acid (E 200), potassium sorbate (E 202) and propyl gallate (E 310)

Regulation (EU) 2024/2597 extends the authorisation of sorbic acid (E 200) and potassium sorbate (E 202) for use as preservatives in water-based, fruit-flavoured gelatine desserts. Furthermore, the...

EU
Infoletter

NEW

Amendment of harmonised standards for personal protective equipment

Regulation (EU) 2016/425 defines requirements for personal protective equipment (PPE). The harmonised standards that can be used for PPE are defined in Implementing Decision (EU) 2023/941. Where a...

EU
Infoletter

NEW

New version of the silicone transition recommendation published

The German Drinking Water Ordinance (TrinkwV) requires the safety of materials and equipment used for the production, treatment or distribution of drinking water that come into contact with drinking...

DE
Infoletter

NEW

Regulation (EU) 2024/1229 supplementing the Regulation on medicated feed to apply soon

In the article referenced below, we informed you about Regulation (EU) 2024/1229 supplementing the Regulation on medicated feed. Specific maximum levels for cross-contamination with antimicrobial...

EU
Reminder

Name of technical standards for radio systems

The regulation on telecommunications systems (FAV) defines basic requirements for radio systems. Product-specific technical designs are specified in technical standards. In agreement with the State...

CH
Infoletter

Term for the IT security label for smart consumer devices has been changed

In the article referenced below, we provided information on the introduction of the new category "Smart consumer devices" for the voluntary IT security label. The IT security mark is issued by the...

DE
Infoletter

NEW

Corrigendum to the ordinance establishing performance classes for the fire resistance of construction products

In the article referenced below, we reported on the entry into force of Delegated Regulation (EU) 2024/1681 supplementing Regulation (EU) No 305/2011 (EU Construction Products Regulation) by...

EU
Infoletter

NEW

Transition period for a preparation of Lentilactobacillus buchneri DSM 19455 ends soon

In the referenced article we informed about the extension of the authorisation of a preparation of Lentilactobacillus buchneri DSM 19455 as a feed additive according to Regulation (EC) No 1831/2003...

EU
Reminder

NEW

ECHA guidance on materials and products in contact with drinking water published

In the article referenced below, we reported on the adoption of various implementing acts that supplement the EU Drinking Water Directive with regard to the requirements for materials and substances...

EU
Infoletter

NEW

Transitional periods for some feed additives will end soon

In the article referenced below, we reported on the re-evaluation of various feed additives. Preparations of Lentilactobacillus plantarum DSM 3676 and 3677 and Lentilactobacillus buchneri DSM 13573...

EU
Reminder

NEW

Corrigendum to the EU marketing standards for eggs - concerns the Hungarian language version of a farming method

In the article referenced below, we reported on the publication of revised marketing standards for eggs. A corrigendum to Regulation (EU) 2023/2465 has now been published, which concerns the Hungarian...

EU
Infoletter

Authorisation of glucosyl hesperidin as a novel food

Only novel foods authorised and included in the Union list of novel foods may be placed on the market within the Union. Regulation (EU) 2025/167 authorises glucosyl hesperidin as a novel food for use...

EU
Infoletter

NEW

Update of the FAQ on EU fertiliser products

Regulation (EU) 2019/1009 lays down the rules for the making available on the market of EU fertiliser products and their labelling. EU fertiliser products are fertiliser products with CE marking. The...

EU
Infoletter

NEW

Formal correction of the Swiss Fertiliser Ordinance

In the article referenced below, we reported on the total revision of the Swiss Fertiliser Ordinance (DüV). It was largely adapted to EU law and thus to Regulation (EU) 2019/1009. A formal correction...

CH
Infoletter

Correction of the EU Battery Regulation

The Battery Regulation (EU) 2023/1542 contains provisions on the entire life cycle of batteries and their sustainability, labelling and safety. The conformity assessment of batteries shall be carried...

EU
Infoletter
11.02.2025

NEW

Corrigendum to the EU Biocidal Products Regulation

The Regulation on biocidal products (EU) No 528/2012 governs the placement on the market and use of biocidal products such as disinfectants, wood preservatives or pesticides. In principle, biocidal...

EU
Infoletter

New version of the guidelines for fine baked goods

The German Food Code is a collection of guidelines which describe the manufacturing, composition or other characteristics of numerous foods. The guidelines for fine baked goods have now been revised...

DE
Infoletter

NEW

Draft regulation on good manufacturing practice (GMP) for veterinary medicinal products published

The planned EU regulation is intended to define requirements for good manufacturing practice (GMP) for veterinary medicinal products in order to ensure the quality, safety and efficacy of these...

EU
(Legal) draft

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