Unbedenklichkeitserklärung im Grundstoffbereich Ausstellung

Do you need a certificate to present to customs or an authority in a third country for the import of raw materials, mixtures containing raw materials or natural products? Then you can apply for a clearance certificate.

You need declarations of no objection so that your supplier in the third country can obtain an export license for

• a basic substance,
• a mixture containing a basic substance or
• a natural product containing basic substances.

Precursors are also formally referred to as scheduled substances and are suitable for the manufacture of narcotics. Mixtures of substances or natural products are classified as basic substances if they can be easily used or if the basic substance they contain can be easily and economically recovered from them.

You can apply to the Federal Institute for Drugs and Medical Devices (BfArM) for a declaration of safety 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
    • or mixtures containing these substances if they can be easily and economically recovered therefrom
• drop shipments of the following raw materials:
  • Category 1
    • 1-phenyl-2-propanone
    • Methyl alpha-acetyl phenyl acetate (MAPA)
    • Methyl 2-methyl-3-phenyl-2-oxiranecarboxylate (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 easily and economically recovered from it

More detailed information on the substances can be found in the relevant legal bases.

The handling of these substances and mixtures or natural products containing these substances may require

• a permit or registration and
• an export license may be required for exports to third countries.

• Application for a declaration of no objection
• For mixtures or natural products:
  • Certificate of analysis or safety data sheet or both
  • For drop shipments of Category 1 commodities: Import authorization of the consignee in the third country (copy)

• You are based in Germany.
• When applying for a declaration of no objection for drop shipments of category 1 precursors: You have a permit.
• When applying for a declaration of no objection for a category 2 precursor: You have a registration.

There are no fees.

You can apply for the declaration of no objection online or by post.

Online:

• Call up the form via the federal portal.
• Complete the application online, attach any documents as files and submit it online.
• The BfArM will check your application. It will contact you if it requires further information.
• If you are granted the declaration of no objection, the BfArM will issue the certificate. The authority will then send it to you by post.

By post:

• Send an informal application to the BfArM, together with any further documents required.
• The BfArM will check your application. It will contact you if it requires further information.
• If you are granted a declaration of no objection, the BfArM will issue the certificate. The authority will then send it to you by post.

There are no indications or special features.

• Appeal.
  Detailed information on how to lodge an objection can be found in the notification of your application.

• Precursors are chemicals that can be used to manufacture narcotics. A permit or registration may be required to handle them. Mixtures of substances or natural products also fall under precursors if they themselves can be used easily or if the precursor they contain can be easily and economically recovered from them.
  • Declarations of no objection are certificates intended for presentation to customs or authorities in third countries. They are issued on application 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
        • 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-acetylphenyl acetate (MAPA)
        • Methyl 2-methyl-3-phenyl-2-oxiranecarboxylate (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 from them.
  • the import of mixtures of substances or natural products containing a basic substance of category 1 if it cannot be easily and economically recovered therefrom
• Costs: No fees are charged.
• Processing time: The average processing time is 14 days.
• Deadlines: There are no deadlines.