SG 85/24
Peru has strengthened the nation’s requirements for chemicals in the manufacture of baby items. The new specifications became effective in April 2024.
In April 2024, Peru’s Ministry of Health (Ministerio de Salud, MINSA) issued Directorial Resolution No. 52-2024-DIGEMID-DG-MINSA (Resolución Directoral Nº 052-2024-DIGEMID-DG-MINSA, the Resolution) to strengthen the chemical requirements for baby products.
The resolution contains several important provisions. It:
- Bans the use of bisphenol A (BPA) for manufacturing baby products (see Table 1)
- Restricts N-nitrosamines and N-nitrosatable substances in baby items containing certain materials (see Table1)
- Restricts two groups of phthalates for baby products containing polyvinyl chloride (PVC) materials (see Table1)
- Restricts 19 (soluble) elements in three categories of baby product – liquid feeding products, pacifiers and teethers, with each category having its own set of requirements (see Table 2)
| Item | Substance | Scope | Requirement |
| 1 | Bisphenol A (BPA) | Baby items | Prohibited |
| 2 | N-Nitrosamines | Baby items made of vulcanized rubber, silicone or thermoplastic elastomer | < 0.01 mg/kg (sum) |
| 3 | N-nitrosatable substances | Baby items made of vulcanized rubber, silicone or thermoplastic elastomer | < 0.1 mg/kg (sum) |
| 4 | DIDP DINP DNOP | Baby items made of PVC | ≤ 0.1% |
| 5 | BBP DBP DEHP DIBP | Baby items made of PVC | < 0.1% |
Table 1
| Element | Liquid feeding products (bottles, food bags, liquid feeding cups and nipples, among others) | Pacifiers (teats or lollipops) | Teethers |
| Aluminum (Al) | 6,000 mg/kg | 1,430 mg/kg | 28,130 mg/kg |
| Antimony (Sb) | 120 mg/kg | 60 mg/kg | 560 mg/kg |
| Arsenic (As) | 10 mg/kg | 5.0 mg/kg | 47 mg/kg |
| Barium (Ba) | 4,000 mg/kg | 2,000 mg/kg | 18,750 mg/kg |
| Boron (B) | 3,200 mg/kg | 1,600 mg/kg | 15,000 mg/kg |
| Cadmium (Cd) | 3.6 mg/kg | 1.8 mg/kg | 17 mg/kg |
| Chromium (Cr) (III) | 100 mg/kg | 50 mg/kg | 460 mg/kg |
| Chromium Cr (VI) | 0.002 mg/kg | 0.001 mg/kg | 0.053 mg/kg |
| Cobalt (Co) | 28 mg/kg | 14 mg/kg | 130 mg/kg |
| Copper (Cu) | 1,660 mg/kg | 830 mg/kg | 7,700 mg/kg |
| Lead (Pb) | 5.0 mg/kg | 2.5 mg/kg | 23 mg/kg |
| Manganese (Mn) | 600 mg/kg | 300 mg/kg | 15,000 mg/kg |
| Mercury (Hg) | 20 mg/kg | 10 mg/kg | 94 mg/kg |
| Nickel (Ni) | 56 mg/kg | 28 mg/kg | 930 mg/kg |
| Selenium (Se) | 100 mg/kg | 50 mg/kg | 460 mg/kg |
| Strontium (Sr) | 12,000 mg/kg | 6,000 mg/kg | 56,000 mg/kg |
| Tin (Sn) | 40,000 mg/kg | 20,000 mg/kg | 180,000 mg/kg |
| Organic tin | 2.5 mg/kg | 1.3 mg/kg | 12 mg/kg |
| Zinc (Zn) | 10,000 mg/kg | 5,000 mg/kg | 46,000 mg/kg |
Table 2
The resolution became effective on April 28, 2024 – the day of its publication in the Peruvian Official Journal. It repeals the chemical requirements under Directorial Resolution No. 159-2022-DIGEMID-DG-MINSA for the manufacture of baby items.
Abbreviations
| Item | Abbreviation | Name of phthalate |
| 1 | BBP | Benzyl butyl phthalate |
| 2 | DBP | Dibutyl phthalate |
| 3 | DEHP | Di(2-ethylhexyl) phthalate |
| 4 | DIBP | Diisobutyl phthalate |
| 5 | DIDP | Diisodecyl phthalate |
| 6 | DINP | Diisonyl phthalate |
| 7 | DNOP | Di-n-octyl phthalate |
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