Table 1.
Overview of requirements for substances per EU regulatory area. All 136 identified information requirements are grouped within one of twenty information requirement categories. A comprehensive overview is provided in Supplementary Information Table S2. Numbers in brackets in the first column indicate the total number of different information requirements per category. Next columns indicate numbers per regulatory area. Hyphens (−) indicate that there is no information requirement for a given regulatory area. Numbers in bold indicate that all information requirements in that category are required for the specific regulatory area.
| Information requirement category with in brackets the total number of identified requirements per category | EU regulatory area |
||||||
|---|---|---|---|---|---|---|---|
| REACHa | Cosmetics | Food and feedb | Biocides | Medicinal products for human use | Medical devices | Veterinary medicinal products | |
| Physico-chemical properties | |||||||
| Chemical name/identifier and molecular structural properties (9) | 9 | 9 | 9 | 9 | 9 | 9 | 9 |
| Composition and (im)purities (7) | 7 | 7 | 7 | 7 | 7 | 7 | 7 |
| Physical descriptors of nanoform/substance (e.g. size, shape, surface) and production methods (13) | 9 | 11 | 12 | 9 | 9 | 12 | 6 |
| Basic physical-chemical properties (e.g. melting/freezing/boiling point, vapor pressure, pH, KOW) (16) | 11 | 15 | 10 | 16 | 12 | 8 | 14 |
| Stability in relevant media (3) | 1 | 3 | 3 | 2 | 2 | 2 | 1 |
| Flammability and explosive properties (5) | 5 | 3 | 1 | 5 | – | 2 | – |
| Interaction with drugs and other active ingredients (3) | – | – | – | – | 3 | 2 | 1 |
| Human health | |||||||
| Sensitisation, irritation and inflammation (10) | 7 | 8 | 3 | 4 | 8 | 6 | 3 |
| Cytotoxicity and reactivity (3) | – | 2 | 3 | 1 | – | 2 | 2 |
| Genotoxicity, mutagenicity, carcinogenicity (5) | 5 | 4 | 5 | 5 | 5 | 5 | 5 |
| Acute/short term toxicity (4) | 4 | 1 | 4 | 4 | 1c | 4 | 3 |
| Long term toxicity (e.g. sub-chronic, reproduction) (6) | 6 | 4 | 5 | 4 | 4 | 6 | 3 |
| Uptake/kinetics (4) | 1 | 3 | 1 | 2 | 2 | 1 | 2 |
| Other requirements (endocrine disruption, neurotoxicity, immunotoxicity, microbiome interactions, use of data in humans, bioburden control and pharmacodynamics parameters) (7) | 2 | 2 | 5 | 4 | 3 | 1 | 5 |
| Effects on biotic systems | |||||||
| Invertebrate toxicity (8) | 6 | – | 8 | 7 | 3 | – | 8 |
| Plants and algae toxicity (4) | 3 | – | 3 | 3 | 3 | – | 3 |
| Microbial toxicity (2) | 2 | – | 1 | 2 | 2 | – | 1 |
| Fish (toxicity and accumulation) (6) | 6 | – | 4 | 6 | 3 | – | 4 |
| Long term testing in birds or mammals (5) | 1 | – | 3 | 3 | – | – | – |
| Environmental fate and behaviour | |||||||
| (A)biotic degradation (12) | 9 | – | 12 | 11 | 5 | – | 8 |
| Fate and behaviour in the environment (4) | 4 | – | 4 | 4 | 4 | – | 4 |
Note that requirements for REACH in this overview are limited to those mentioned in the Annexes VI-X in the REACH regulation (EC, 2006; EU, 2018).
The food and feed regulatory area as depicted in this table includes several regulations along the food and feed chain, including PPPs and novel foods, see also the Supplementary information for a list of considered documents (Table S1).
Acute toxicity is an information requirement within Directive 2001/83/EC on the Community code relating to medicinal products for human use (EC, 2001). However, since then it has been agreed to remove the guideline on single dose toxicity for medicinal products because the data obtained in single dose toxicity studies is considered to be of limited value and because information on acute toxicity can be obtained in other types of toxicity studies (EMA, 2010).