Basic materials for medical devices; application for a declaration of no objection

If you require a certificate for submission to customs or an authority in a third country for the import of raw materials or mixtures containing raw materials or natural products, you can apply for a declaration of no objection.

Street address

Kurt-Georg-Kiesinger-Allee 3
53175 Bonn

Postal address

Kurt-Georg-Kiesinger-Allee 3

53175 Bonn

Mehr zur Behörde

Safety declarations can be important for you so that your supplier in the third country is granted an export permit by its authority for the precursor or the mixture or the natural product, if this substance is contained.
Precursors are also formally referred to as scheduled substances and are suitable for manufacturing narcotics. Mixtures of substances or natural products fall under precursors if they themselves can be easily used or the precursor they contain can be easily and economically recovered from them.
You can apply for a declaration of no objection for

the import of the following substances into the European Union:
- Category 2
  - Red phosphorus
  - acetic anhydride
  - phenylacetic acid
  - anthranilic acid
  - piperidine
  - potassium permanganate and
  - the salts of the listed substances, if the presence of such salts is possible
  - or mixtures containing these substances if they can be easily and economically recovered therefrom
- Category 3
  - Hydrochloric acid
  - sulphuric acid
  - toluene
  - ethyl ether
  - acetone
  - methyl ethyl ketone and
  - the salts of the listed substances, provided that the presence of such salts is possible and they are not salts of hydrochloric acid and sulphuric acid
  - or mixtures containing these substances if they can be easily and economically recovered therefrom
Drop shipments of the following commodities:
- Category 1
  - 1-phenyl-2-propanone
  - Methyl alpha-acetyl phenyl acetate (MAPA)
  - Methyl 2-methyl-3-phenyl-2-oxirane carboxylate (BMK methyl glycidate)
  - 2-Methyl-3-phenyl-2-oxiranecarboxylic acid (BMK glycidic acid)
  - N-acetylanthranilic acid
  - Alpha-phenylacetoacetamide (APAA)
  - Alpha-phenylacetoacetonitrile (APAAN)
  - Isosafrole (cis + trans)
  - 3,4-Methylenedioxyphenyl-propan-2-one
  - piperonal
  - safrole
  - Methyl 3-(1,3-benzodioxol-5-yl)-2-methyl-2-oxiranecarboxylate (PMK methyl glycidate)
  - 3-(1,3-benzodioxol-5-yl)-2-methyl-2-oxiranecarboxylic acid (PMK-glycidic acid)
  - 4-anilino-N-phenethylpiperidine (ANPP)
  - N-phenethyl-4-piperidone (NPP)
  - ephedrine
  - Pseudoephedrine
  - Norephedrine
  - ergometrine
  - ergotamine
  - lysergic acid
  - (1R,2S)-(-)-Chlorephedrine
  - (1S,2R)-(+)-Chlorephedrine
  - (1S,2S)-(+)-chloropseudoephedrine
  - (1R,2R)-(-)-chloropseudoephedrine
  - the stereoisomers of the listed substances with the exception of cathine, where the existence of such forms is possible.
  - the salts of the listed substances, insofar as the existence of such salts is possible and they are not salts of cathine.
- substances of the above categories 2 and 3
- or mixtures containing these substances if they can be easily and economically recovered therefrom.
the import of mixtures of substances or natural products containing a Category 1 basic substance if it cannot be readily and economically recovered therefrom

More detailed information on the substances can be found in the relevant legal bases.
The handling of these substances or mixtures or natural products containing these substances may require

a permit or registration and
an export license is required for exports to third countries.

You must be resident in Germany.
When applying for a declaration of no objection for drop shipments of category 1 precursors, you must be in possession of a permit.
When applying for a declaration of no objection for a category 2 precursor, you must be in possession of a registration.

Required Documents
Für Mischungen oder Naturprodukte:
- Analysenzertifikat oder Sicherheitsdatenblatt oder beides
- bei Streckengeschäften mit Grundstoffen der Kategorie 1: Kopie der Einfuhrgenehmigung des Empfängers im Drittland

You can apply for the declaration of no objection informally by e-mail or post. The BfArM will check your application. If further information is required, the BfArM will contact you. If you are granted the declaration of no objection, the BfArM will send it to you by your preferred method.

There are no fees for you.

The declarations of no objection are generally valid for between 6 and 12 months. In the case of drop shipments, the period of validity of the declaration of no objection depends on any import license issued by the recipient.