Regulatory Updates

Over-the-Counter Human Drugs; Labelling Requirements (9 pages, in English).

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Distribution date: 18 December 2006

The Food and Drug Administration (FDA) is proposing to amend its final rule that established standardized format and content requirements for the labelling of over-the-counter (OTC) drug products (Drug Facts Rule, codified at 21 CFR 201.66). This amendment proposes a definition and the option of alternative labeling requirements for "convenience-size" OTC drug packages.

Products Covered: Over-the-counter human drugs (HS:  Chapter 3004) (ICS:  11)

Regulation Type: Regular notification

Over-the-Counter Human Drugs; Labelling Requirements (9 pages, in English).

Product Image

Distribution date: 18 December 2006

The Food and Drug Administration (FDA) is proposing to amend its final rule that established standardized format and content requirements for the labelling of over-the-counter (OTC) drug products (Drug Facts Rule, codified at 21 CFR 201.66). This amendment proposes a definition and the option of alternative labeling requirements for "convenience-size" OTC drug packages.

Products Covered: Over-the-counter human drugs (HS:  Chapter 3004) (ICS:  11)

Regulation Type: Regular notification

Assessment Report for Application A587 – Maximum Residue Limits – Oxytetracycline (Antibiotic) (21 pages in English).

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Distribution date: 18 December 2006

This Application seeks to amend the Australia New Zealand Food Standards Code (the Code) to align the maximum residue limit (MRL) for the antibiotic oxytetracycline in honey with other national regulations relating to the safe and effective use of agricultural and veterinary chemicals.

Products Covered: Foods in general

Regulation Type: Regular notification

Food safety Human health Veterinary drugs Maximum residue limits (MRLs)

Assessment Report for Application A587 – Maximum Residue Limits – Oxytetracycline (Antibiotic) (21 pages in English).

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Distribution date: 18 December 2006

This Application seeks to amend the Australia New Zealand Food Standards Code (the Code) to align the maximum residue limit (MRL) for the antibiotic oxytetracycline in honey with other national regulations relating to the safe and effective use of agricultural and veterinary chemicals.

Products Covered: Foods in general

Regulation Type: Regular notification

Food safety Human health Veterinary drugs Maximum residue limits (MRLs)

Proposed Revocation of Veterinary Drug Residue Limits (Available in English, 1 page).

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Distribution date: 08 December 2006

MRLs for the veterinary drug Nitrofurazone are proposed to be revoked since the use of this drug has been banned.

Products Covered: Cattle, pigs, sheep, goats and poultry.

Regulation Type: Regular notification

Food safety Human health Maximum residue limits (MRLs) Veterinary drugs

Proposed Revocation of Veterinary Drug Residue Limits (Available in English, 1 page).

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Distribution date: 08 December 2006

MRLs for the veterinary drug Nitrofurazone are proposed to be revoked since the use of this drug has been banned.

Products Covered: Cattle, pigs, sheep, goats and poultry.

Regulation Type: Regular notification

Food safety Human health Maximum residue limits (MRLs) Veterinary drugs

KS 1822:2006 Solvent based universal undercoat — Specification (5 pages in English).

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Distribution date: 28 November 2006

Products Covered: Paints and varnishes (HS:  320910; ICS:  87.040)

Regulation Type: Regular notification

KS 1822:2006 Solvent based universal undercoat — Specification (5 pages in English).

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Distribution date: 28 November 2006

Products Covered: Paints and varnishes (HS:  320910; ICS:  87.040)

Regulation Type: Regular notification

KS 1831, 2006 Solvent-based paint remover — Specification (19 pages in English).

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Distribution date: 28 November 2006

Products Covered: Paint removers (HS:  340220; ICS:  71.100.40, 87.040)

Regulation Type: Regular notification

KS 1831, 2006 Solvent-based paint remover — Specification (19 pages in English).

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Distribution date: 28 November 2006

Products Covered: Paint removers (HS:  340220; ICS:  71.100.40, 87.040)

Regulation Type: Regular notification

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